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Latest Regulatory News Arzerra™ Granted Accelerated Approved for Refractory Chronic Lymphocytic Leukemia (10/28/2009)Arzerra™ (ofatumumab) has been granted accelerated approval by the U.S. Food and Drug Administration for treatment of patients with chronic lymphocytic leukemia (CLL) that is refractory to Fludara® (fludarabine) and Campath® (alemtuzumab). Second HPV Vaccine Approved in U.S. (10/16/2009) The U.S. Food and Drug Administration has approved Cervarix®, a vaccine against two high-risk types of human papillomavirus (HPV), for prevention of cervical cancer and cervical precancers. This is the second HPV vaccine to be approved in the United States. FDA Advisory Committee Reviews Prolia™ (Denosumab) (8/14/2009) On August 13, 2009, the U.S. Food and Drug Administration’s Advisory Committee on Reproductive Health Drugs (ACRHD) reviewed the potential use of Prolia™ (denosumab) for the prevention and treatment of postmenopausal osteoporosis and the prevention and treatment of bone loss in patients undergoing hormone ablation for either prostate cancer or breast cancer. Sprycel® Gets Full Approval for Adults with Chronic Myeloid Leukemia (6/24/2009) The U.S. Food and Drug Administration (FDA) has granted full approval to Bristol-Myers Squibb Company’s agent Sprycel® (dasatinib) for the treatment of adult patients in all phases of chronic myeloid leukemia (CML) who are resistant or intolerant to prior therapies including Gleevec® (imatinib mesylate). Avastin® Approved for Progressive Glioblastoma (6/24/2009) The U.S. Food and Drug Administration (FDA) has approved Avastin® (bevacizumab) as a single agent for the treatment of glioblastoma that has progressed following prior therapy. The approval is based on objective response rates. New Drug Application Approved for MonoSol Rx’s Ondansetron Orally Dissolving Film Strips (6/24/2009) The U.S. Food and Drug Administration (FDA) has approved MonoSol Rx’s new drug application (NDA) for ondansetron orally dissolving film strips (ODFS) utilizing the PharmaFilm® technology. Action Date for Ofatumumab BLA Extended by Three Months (6/17/2009) The U.S. Food and Drug Administration (FDA) has extended the action date for review of the biologics license application (BLA) of GlaxoSmithKline and Genmab A/S’s investigative agent ofatumumab by three months. Fast Track Designation Granted for Talactoferrin (6/17/2009) Agennix Inc. has been granted fast track designation by the U.S. Food and Drug Administration (FDA) for their investigative agent talactoferrin alfa (talactoferrin) for first-line therapy of renal cell carcinoma (RCC) in combination with Sutent® (sunitinib). Delcath Receives Orphan Drug Designation for Treatment of Neuroendocrine Tumors (6/17/2009) Delcath Systems, Inc. has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for the use of high-dose melphalan in the treatment of neuroendocrine tumors, utilizing their proprietary drug-delivery system Orphan Drug Designation Denied for ADXS11-001 (6/16/2009) The U.S. Food and Drug Administration (FDA) has denied the request by Advaxis, Inc. for orphan drug designation (ODD) for their investigative agent ADXS11-001. The request for the ODD included the indication for ADXS11-001 in the treatment of invasive cervical cancer. Tarceva®’s sNDA Accepted for Filing and Review (6/16/2009) The supplemental new drug application (sNDA) for OSI Pharmaceuticals, Inc.’s agent Tarceva® (erlotinib) has been accepted for filing and review by the U.S. Food and Drug Administration (FDA). The sNDA is indicated for Tarceva to be used as first-line maintenance therapy among patients who have not progressed following first-line platinum-based therapy. Afinitor® Approved for Treatment of Advanced Renal Cell Carcinoma After Failure of Sutent® or Nexavar® (3/31/2009) Novartis’ Afinitor® (everolimus) has been approved by the United States Food and Drug Administration for patients with advanced renal cell carcinoma (RCC) after failure of treatment with Sutent® (sunitinib) or Nexavar® (sorafenib). NDA Submitted for Pralatrexate for Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma (3/26/2009) Allos Therapeutics, Inc. has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for the use of pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The company has requested a priority review of the application. There are currently no agents approved by the FDA for the treatment of patients with PTCL. SGN-35 Receives Orphan Drug Designation (1/28/2009) Seattle Genetics, Inc. received orphan drug designations from the U.S. Food and Drug Administration (FDA) for their investigative agent SGN-35 for the treatment of anaplastic large cell lymphoma (ALCL). The agent also has orphan drug status for the treatment of Hodgkin’s lymphoma. SBLA for Erbitux® in Lung Cancer Withdrawn (1/27/2009) ImClone Systems and Bristol-Meyers Squibb Company have withdrawn their supplemental biologics application (sBLA) from the U.S. Food and Drug Administration (FDA) for Erbitux® (cetuximab) to be used in the treatment of non-small cell lung cancer (NSCLC). Complete Response Letter Issued for Gardasil® sBLA for Use in Older Women (1/13/2009) The United States Food and Drug Administration (FDA) has issued a second response letter to Merck & Co, Inc. in regards to their supplemental biologics license application (sBLA) for use of Gardasil® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant] for women ages 27 to 45. FDA Considering Gardasil® for Boys (1/8/2009) Merck & Co. has submitted an application to the Untied States Food and Drug Administration (FDA) to consider Gardasil®, the vaccine against the human papillomavirus, in boys 9 to 26 years to prevent genital warts and other lesions. The FDA has two months to make a decision as to whether the new application meets its standards. IND Granted to Triphendiol (1/8/2009) The United States Food and Drug Administration has granted Marshall Edwards, Inc. an investigative new drug (IND) indication for triphendiol (NV-196). Degarelix Approved for Advanced Prostate Cancer (12/30/2008) The United States Food and Drug Administration (FDA) has approved Ferring Pharmaceuticals’ agent degarelix for the treatment of advanced, hormone-sensitive prostate cancer. Several trade names for degarelix are currently under review with the FDA; once a chosen trade name is approved, marketing for the agent in its approved indication can begin. Mozobil™ Approved for Stem Cell Mobilization in NHL and MM Patients (12/30/2008) Genzyme Corporation has been granted marketing approval by the United States Food and Drug Administration (FDA) for their agent Mozobil® (plerixafor injection). This approval is for use in combination with granulocyte-colony stimulating factor (G-CSF) for the mobilization of hematopoietic stem cells for collection and use in autologous stem cell transplants in patients with non-Hodgkins lymphoma (NHL) and multiple myeloma (MM). The FDA has also granted Mozobil orphan drug designation. BLA Submitted for Denosumab (12/29/2008) Amgen Inc. has submitted a biologics license application (BLA) to the United States Food and Drug Administration for their investigative agent denosumab. The BLA is for the treatment and prevention of postmenopausal osteoporosis in women and treatment and prevention of bone loss among patients undergoing hormone ablation for breast or prostate cancer. Gleevec® Approved to Prevent Recurrences of GIST (12/29/2008) Novartis’s Gleevec® (imatinib mesylate) has been approved by the United States Food and Drug Administration for treatment following the complete surgical removal of Kit (CD117)-positive gastrointestinal stromal tumors (GIST) in adults. Zevalin® Receives Priority Review Status for sBLA as First-line Consolidation Therapy in NHL (12/9/2008) The U.S. Food and Drug Administration has granted Cell Therapeutics, Incorporated priority review for Zevalin® ([90Y]-ibritumomab tiuxetan) as consolidation therapy for patients with follicular B-cell non-Hodgkin’s lymphoma (NHL) who achieve a response to initial therapy. Cell Therapeutics recently submitted a supplemental biologics license application (sBLA) for Zevalin to be used in this expanded indication. Tesetaxel Receives Orphan Drug Designation for Advanced Melanoma (12/9/2008) Genta Incorporated received orphan drug designation from the U.S. Food and Drug Administration for their investigative agent tesetaxel in the treatment of advanced melanoma. sNDA Filed for Clolar® to Treat AML (12/9/2008) Genzyme Corporation has filed a supplemental New Drug Application (sNDA) for the use of their agent Clolar® (clofarabine) in the treatment of adults with acute myeloid leukemia (AML). Specifically, the sNDA seeks approval for the use of Clolar as a single agent in patients 60 years or older who have at least one unfavorable prognostic factor with previously untreated AML. Pralatrexate Receives Orphan Drug Designation for Diffuse Large B-cell and Follicular Lymphomas (12/9/2008) The U.S. Food and Drug Administration has granted Allos Therapeutics, Inc. orphan drug designation for their investigative agent pralatrexate (PDX) in the treatment of diffuse large B-cell and follicular lymphomas. PEP02 Receives IND Approval (12/8/2008) PharmaEngine, Incorporated has received approval from the U.S. Food and Drug Administration for an investigational new drug (IND) application submitted for the investigative agent PEP02 (liposome irinotecan injection) in the treatment of pancreatic cancer. NDA Submitted for Trabectedin for Treatment of Ovarian Cancer (12/8/2008) Ortho Biotech Products, L.P. has submitted a new drug application (NDA) to the United States Food and Drug Administration for their novel agent trabectedin to be used in combination with Doxil® (doxorubicin HCI liposome injection) for the treatment of relapsed ovarian cancer. Genta Receives Complete Response Letter for Genasense® NDA in CLL (12/8/2008) The Office of Oncology Drug Products (OODP) at the United States Food and Drug Administration (FDA) has indicated the need for additional clinical study for potential approval of the new drug application (NDA) submitted by Genta Incorporated for their agent Genasense® (oblimersen sodium injection) in the treatment of chronic lymphocytic leukemia. BD FocalPoint™ GS Imaging System Receives Pre-market Approval for Cervical Cancer Screening (12/8/2008) BD Diagnostics received premarket approval (PMA) by the U.S. Food and Drug Administration (FDA) for their system, BD FocalPoint GS Imaging System, to enhance screening effectiveness for squamous carcinoma and adenocarcinoma of the cervix as well as precursor conditions of the cervix in cytology laboratories utilizing the BD SurePath™ Pap test slides. Spectrum Pharmaceuticals Files Supplemental NDA for Fusilev™ (11/4/2008) Spectrum Pharmaceuticals, Inc. has filed a supplemental new drug application (NDA) with the U.S. Food and Drug Administration for an expanded indication for its agent Fusilev™ (levoleucovorin). Genentech Seeks sBLA for Avastin® in Glioblastoma (11/4/2008) Genentech, Inc. has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration for their agent Avastin® (bevacizumab) to be used as second-line therapy in glioblastoma. Treanda® Approved for Relapsed Indolent Non-Hodgkin's Lymphoma (11/3/2008) The United States Food and Drug Administration has approved Cephalon's Treanda® (bendamustine hydrochloride) for injection for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma that has progressed during or within six months of therapy with Rituxan® (rituximab) or Rituxan-containing regimens. Supplemental Biologics License Application (SBLA) Accepted and Priority Review Granted for Erbitux® for Head and Neck Cancer (11/3/2008) The United States Food and Drug Administration (FDA) has accepted ImClone Systems Incorporated and Bristol-Myers Squibb Company's SBLA submission for filing that includes the broadening of the indication of Erbitux® (cetuximab) to include its use in combination with platinum-based chemotherapy for the first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). RTA 402 Granted Orphan Drug Designation (10/27/2008) The United States Food and Drug Administration (FDA) has granted orphan drug status to Reata Pharmaceuticals, Inc. for their agent RTA 402 in the treatment of pancreatic cancer. FDA Grants Full Approval of Ontak® (10/24/2008) The United States Food and Drug Administration (FDA) has granted Eisai Pharmaceuticals full approval for their agent Ontak (denileukin diftitox). Ontak is now approved for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose cancer cells express the CD25 component of the IL-2 receptor. FDA Meeting Provides Green Light for Cell Therapeutics Submission of Supplemental Filing for Zevalin® Label Expansion (9/24/2008) Supplemental Biologics License Application (sBLA) on track for Q4 Submission. Oral Form of Aloxi® Approved (8/28/2008) The United States Food and Drug Administration (FDA) has approved the oral capsule formulation of Eisai’s Aloxi® (palonosetron) for the prevention of chemotherapy-induced nausea and vomiting. Vidaza® Receives Expanded Indication for MDS (8/25/2008) The U.S. Food and Drug Administration has granted Celgene Corporation’s Vidaza® (azacitidine) an expanded indication that includes higher-risk myelodysplastic syndrome patients. Vidaza is already approved for five MDS subtypes, according to the French American British classification; these subtypes include refractory anemia or refractory anemia with ringed sideroblasts if accompanied by neutropenia or thrombocytopenia or requiring transfusions, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia. OGX-011 Receives Fast-track Status (8/25/2008) The U.S. Food and Drug Administration (FDA) recently granted OncoGenex Pharmaceuticals fast-track designation for their investigative agent OGX-011 (custirsen sodium) for the treatment of prostate cancer. Specifically, the designation includes the use of OGX-011 in combination with Taxotere® (docetaxel) for the treatment of progressive, metastatic prostate cancer. Nplate® Approved for ITP (8/25/2008) Amgen’s platelet simulator Nplate® (romiplostim) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with chronic immune thrombocytopenic purpura (ITP) who are refractory to standard therapy. MP-470 Granted Orphan Drug Status for Glioblastoma (8/8/2008) The U.S. Food and Drug Administration (FDA) has granted SuperGen, Inc. orphan drug designation for their targeted agent MP-470 in the treatment of glioblastoma multiforme. VEGFb™ Granted Orphan Drug Status for Melanoma (7/29/2008) The United States Food and Drug Administration (FDA) has granted PhiloGene, Inc. orphan drug designation for their investigative agent VEGFb. The designation is for the treatment of patients with stages IIb through stage IV melanoma. Polyphenon E® Granted Orphan Drug Designation (7/28/2008) The United States Food and Drug Administration (FDA) has granted Polyphenon Pharma orphan drug designation for their investigative agent Polyphenon E® for the treatment of chronic lymphocytic leukemia (CLL). IND Filed for SPI-3005 (7/25/2008) Sound Pharmaceuticals (SPI) has filed an investigative new drug (IND) application with the United States Food and Drug Administration (FDA) for their investigative oral agent SPI-3005 (ebselen). The IND is for use of SPI-3005 for the prevention of hearing loss (ototoxicity) induced by chemotherapy. MicroRNA Test Distinguishes Between Squamous and Non-Squamous Lung Cancer (7/25/2008) Rosetta Genomics Ltd. has received regulatory approval for their diagnostic test using MicroRNA technology to differentiate between squamous and non-squamous non-small cell lung cancer (NSCLC). SPOT-Light Cleared for HER2 Testing (7/9/2008) The U.S. Food and Drug Administration (FDA) has approved Invitrogen Corp’s genetic test SPOT-Light HER2 CISH for the identification of HER2-positivity among breast cancer patients. FDA Grants Marketing Clearance to AMDL-ELISA DR-70® (FDP) for Monitoring Colorectal Cancer (7/9/2008) The U.S. Food and Drug Administration (FDA) has granted marketing clearance to AMLD, an bio-pharmaceutical company, for their device, DR-70, to detect for recurrences or progression of disease among patients diagnosed with colorectal cancer. Clinical Hold Lifted for Entereg® (7/7/2008) The U.S. Food and Drug Administration (FDA) has lifted its clinical hold on Adolor Corporation’s constipation drug Entereg® (alvimopan). Entereg is being developed with GlaxoSmithKline PLC for the treatment of chronically constipated patients who are taking opioid drugs for pain. Priority Review Application for Introgen Therapeutics Inc.’s Advexin® p53 (7/1/2008) Introgen Therapeutics Inc. has applied to the U.S. Food and Drug Administration (FDA) for priority review of Advexin p53 for the treatment of recurrent head and neck cancer. FDA Cites Questions Regarding the sBLA for Gardasil® (6/30/2008) The United States Food and Drug Administration (FDA) did not accept Merck & Co., Inc’s supplemental biologics license application (sBLA) for its vaccine Gardasil® (human papillomavirus quadrivalent [Types 6, 11, 16, 18] vaccine, recombinant). Velcade® Approved as Initial Therapy for Multiple Myeloma (6/23/2008) Millennium Pharmaceuticals, The Takeda Oncology Company, and Takeda Pharmaceutical Company Limited have received an additional approval by the United States Food and Drug Administration (FDA) for their agent Velcade® (bortezomib) as initial therapy for multiple myeloma. Velcade is also approved for the treatment of multiple myeloma and mantle cell lymphoma among patients who have received prior therapies. Priority Review Granted to AdreView (6/19/2008) The United States Food and Drug Administration (FDA) has granted GE Healthcare priority review for the new drug application (NDA) of their molecular imaging agent, AdreView (lobenguane I 123 Injection). The NDA was for the detection of neuroendocrine tumors in pediatric and adult patients. NDA Amendment Submitted for Genasense® (6/19/2008) Genta Incorporated has submitted an amendment to the new drug application (NDA) for Genesense® (oblimersen sodium) injection to the United States Food and Drug Administration (FDA). The initial NDA was submitted for Genasense to be used with chemotherapy for the treatment of relapsed or refractory chronic lymphocytic leukemia. LX1032 Granted Fast-track Status for Carcinoid Syndrome (6/19/2008) Lexicon Pharmaceutical’s investigative agent LX1032 has been granted fast-track status by the United States Food and Drug Administration (FDA). 510(k) Clearance Granted for FDA Infusion System (6/19/2008) Medrada, Inc.’s novel fluorodeoxyglucose (FDG) Intego™ PET Infusion System, an infusion system for positron emission tomography/computed tomography (PET/CT) imaging procedures, has been granted 510(k) clearance by the United States Food and Drug Administration. New Herceptin®-Containing Regimens Approved for Adjuvant Breast Cancer (6/4/2008) Genentech’s Herceptin® (trastuzumab) has received additional U.S. Food and Drug Administration approval for two new Herceptin-containing regimens for the adjuvant treatment of early HER2-positive breast cancer. Test for Tumors of Uncertain Origin Launched by Pathwork Diagnostics (5/7/2008) Pathwork Diagnostics has launched the Pathwork tissue origin test, a microarray-based diagnostic test to help diagnose tumors of uncertain origin. Treanda® Approved by FDA for Initial Treatment of CLL (3/25/2008) On March 20, 2008, the U.S. Food and Drug Administration (FDA) approved IV Treanda® (bendamustine) for initial treatment of chronic lymphocytic leukemia (CLL). The results were based on data from a randomized multicenter trial that were presented at the 2007 meeting of the American Society of Hematology (ASH), December 8-11, in Atlanta, Georgia. Change in Schedule for NDA Submission of E7389 (3/14/2008) Eisai Corporation of North America has announced a change in schedule for the submission of a new drug application (NDA) for their agent E7389. The NDA had planned to seek accelerated approval for E7389, however, another drug was approved for this indication in the interim. Because of this, Eisai plans the NDA submission for the 2009-2010 fiscal year, based on results from ongoing phase II clinical trials. Elesclomol Granted Orphan Drug Status (3/4/2008) Elesclomol (formerly STA-4783), an investigative agent being jointly developed by Glaxo-Smith Kline and Synta Pharmaceuticals, Corp., has been granted orphan drug status by the United States Food and Drug Administration (FDA) for the treatment of metastatic melanoma. FDA Approves Avastin® (Bevacizumab) for Breast Cancer (2/25/2008) The United States Food and Drug Administration (FDA) has approved Genentech’s agent Avastin (bevacizumab) for the treatment of advanced breast cancer. Specifically, the indications include Avastin, in combination with Taxol® (paclitaxel) for patients with metastatic human epidermal receptor 2-negative (HER2-negative) breast cancer who have not received prior chemotherapy for metastatic disease. Nplate® (Romiplostim) Set for ODAC Review (2/8/2008) TOP2A FISH pharmDx™ Assay Approved for Market (1/30/2008) Dako PMA has received marketing approval from the United States Food and Drug Administration for their assay TOP2A FISH pharmDx™. This assay is to be used as an adjunct in determining the prognosis for high-risk breast cancer. Herceptin® (Trastuzumab) Approved as Monotherapy in Adjuvant Breast Cancer Setting (1/30/2008) The United States Food and Drug Administration (FDA) has expanded the indication of Herceptin to be used as monotherapy for the adjuvant treatment of HER2-positive breast cancer. Further Review of Anemia Drugs by the FDA (1/11/2008) The United States Food and Drug Administration (FDA) has announced that it is reviewing new data regarding erythropoiesis-stimulating agents (ESAs). ESAs are drugs used to treat anemia. They include Procrit® (epoetin alfa), Epogen® (epoetin alfa), and Aranesp® (darbepoetin alfa). NDA Submitted for Treanda® (1/11/2008) A New Drug Application (NDA) has been submitted to the United States Food and Drug Administration (FDA) by Cephalon, Inc. for their investigative agent Treanda (bendamustine HCl) for the treatment of indolent B-cell non-Hodgkin’s lymphoma (NHL). IND Filed for Cancer Vaccine (12/26/2007) Geron Corporation and Merck & Co. have announced that they have filed an investigative new drug (IND) application with the United States Food and Drug Administration (FDA) for a cancer vaccine targeting telomerase. CellSearch Granted 510(k) Marketing Clearance for Metastatic Colorectal Cancer (12/26/2007) Veridex, LLC has been granted 510(k) marketing clearance for their CellSearch system for the monitoring of metastatic colorectal cancer. Prochymal Receives Fast-Track Status for Initial Treatment of Acute GVHD (12/13/2007) The United States Food and Drug Administration (FDA) has granted Osiris Therapeutics fast-track status for their agent Prochymal™ as initial therapy for acute graft-versus-host-disease (GVHD). ODAC Denies Recommendation for Avastin® (Bevacizumab) Approval for Breast Cancer (12/5/2007) The United States Food and Drug Administration's (FDA's) Oncology Drugs Advisory Committee (ODAC) has recommended against the approval of Genentech’s Avastin (bevacizumab) for the treatment of metastatic breast cancer. Complete SE Biliary Stent System Receives Marketing Clearance (11/29/2007) The United States Food and Drug Administration (FDA) has granted Medtronic Inc. clearance for marketing for their biliary stent system for the treatment of malignancies of the bile duct. sNDA Submitted for Aloxi® (11/29/2007) A supplemental New Drug Application (sNDA) has been submitted to the United States Food and Drug Administration (FDA) by MGI Pharma Inc., and Helsinn Healthcare SA for their agent Aloxi (palonosetron). Aloxi is a 5-HT3 receptor antagonist. Orphan Drug Designation Granted to ATIR (11/27/2007) The United States Food and Drug Administration (FDA) has granted Kiadis Pharma orphan drug designation for their product ATIR for the prevention of Graft-versus-Host-Disease (GVHD). FDA Notifies Healthcare Professionals about Changes in Behavior and Suicidal Thoughts with Chantix (11/27/2007) Pfizer’s drug Chantix (varenicline) for smoking cessation has been linked to a few reports of suicidal thoughts and aggressive and errative behavior. FDA Approves Campath® for First-Line Treatment of B-cell CLL (11/21/2007) In October of 2007 the US Food and Drug Administration (FDA) approved Campath (alemtuzumab) for initial treatment for patients with chronic lymphocytic leukemia (CLL). This is the first monoclonal antibody approved by the FDA for B-cell CLL. ODAC to Discuss New Indication for Avastin® (11/12/2007) The United States Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) has scheduled a meeting on December 5, 2007 to discuss the new indication submitted with the supplemental biologics license application (sBLA) for Genentech’s targeted agent Avastin (bevacizumab). Amgen Revises Labeling on Erythropoietin-stimulating Agents (11/8/2007) Amgen, in collaboration with the United States Food and Drug Administration (FDA) and Johnson and Johnson Pharmaceutical Research & Development, has updated package inserts for Aranesp® (darbepoetin alfa) and Epogen®/Procrit® (epoetin alfa). Tamibarotene Receives Orphan Drug Designation (11/5/2007) The United States Food and Drug Administration (FDA) has granted Innovive Pharmaceuticals, Inc. orphan drug designation for their agent tamibarotene for the treatment of acute promyelocytic leukemia (APL). The indication of the designation is for the treatment of APL that has relapsed or is refractory to all-trans-retinoic acid (ATRA) and arsenic trioxide. Tasigna® Approved for CML (10/30/2007) The United States Food and Drug Administration (FDA) has granted accelerated approval to Novartis Pharmaceuticals Corporation for their agent Tasigna (nilotinib) for the treatment of chronic phase (CP) or accelerated phase (CP) Philadelphia chromosome positive chronic myelogenous leukemia (CML) among patients who are not able to tolerate treatment with Gleevec® (imatinib) or those who have stopped responding to Gleevec. Upon submission of follow-up data from an ongoing trial, the accelerated approval will convert to regular approval for Tasigna. Partial Hold on Telcyta® Development Removed (10/26/2007) The United States Food and Drug Administration (FDA) has removed the partial hold it had placed on the clinical development of Telik, Inc’s investigative small molecule Telcyta (canfosfamide HCL, TLK286). Ixempra™ Approved for Advanced Breast Cancer (10/18/2007) The United States Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s new chemotherapy agent Ixempra (ixabepilone) for the treatment of advanced breast cancer. The indication specifies treatment with Ixempra as “monotherapy for the treatment of patients with metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine. The FDA has also granted approval of IXEMPRA in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline, and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated.” Velcade® Indication Expanded to Include Patients with Impaired Kidney Function (10/17/2007) Millennium Pharmaceuticals, Inc. has received an expanded indication for their agent Velcade (bortezomib) from the United States Food and Drug Administration (FDA) to include patients with multiple myeloma who have impaired kidney function, including those who require dialysis. Oral Hycamtin® (topotecan) Approved for Relapsed Small Cell Lung Cancer (10/16/2007) The United States Food and Drug Administration (FDA) has approved an oral formulation of Hycamtin capsules for the treatment of relapsed small cell lung cancer (SCLC). This approval will allow patients to be treated at home. 510(k) Clearance Granted for AXP AutoXpress™ Platform (10/15/2007) ThermoGenesis Corp., has received 510(k) clearance from the United States Food and Drug Administration (FDA) for their proprietary AXP AutoXpress™ Platform, which has been commercially available since March 2006. Survival Data for Erbitux to be Included in Product Labeling (10/12/2007) The United States Food and Drug Administration (FDA) has approved an update to ImClone Systems Incorporated targeted agent Erbitux (cetuximab) product labeling to include survival data. The new data to be used in the product labeling includes data demonstrating an improved overall survival with the use of single-agent Erbitux versus placebo in patients with advanced colorectal cancer. New Drug Application Submitted for Treanda® (10/8/2007) Cephalon, Inc. has submitted a new drug application (NDA) to the United States Food and Drug Administration (FDA) for their agent Treanda (bendamustine HCL) for the treatment of chronic lymphocytic leukemia (CLL). Taxotere® is granted approval for Head and Neck Cancer (10/1/2007) The United States Food and Drug Administration (FDA) has approved Sanofi-Aventis’ chemotherapy agent Taxotere (docetaxel), in combination with Platinol® (cisplatin) and 5-fluorouracil as induction therapy for locally advanced squamous cell carcinoma of the head and neck (SCCHN) prior to surgery. Evista® Approved to Prevent Invasive Breast Cancer in Postmenopausal Women (9/25/2007) Eli Lilly’s Evista (raloxifene HCL) has been approved to reduce the risk of invasive breast cancer among postmenopausal women who have osteoporosis or postmenopausal women who are at a high risk of developing breast cancer. ALS-357 Granted Orphan Drug Status for Metastatic Melanoma (9/20/2007) The United States Food and Drug Administration (FDA) has granted Advanced Life Sciences Holdings, Inc. orphan drug designation for their agent ALS-351 in the treatment of metastatic melanoma. Not Approvable Letter for Mifamurtide (9/19/2007) IDM Pharma, Inc. has received a not approvable letter from the United States Food and Drug Administration (FDA) for their investigational drug mifamurtide (L-MTP-PE) – formerly Junovan – for the treatment of osteosarcoma. Orphan Drug Designation for Cordycepin (9/12/2007) OncoVista, Inc.’s agent Cordycepin (3’-deoxyadenosine) has been granted orphan drug designation by the United States Food and Drug Administration (FDA). Resubmission of Supplemental Biologics License Application for Avastin® (9/11/2007) Genentech has announced that it has resubmitted a supplemental biologics license application for its targeted agent Avastin (bevacizumab) for initial treatment of metastatic breast cancer to be used in combination with Taxol® (paclitaxel). sNDA Application Submitted for Nexavar® (9/10/2007) A supplemental new drug application (sNDA) has been submitted by Bayer Healthcare Pharmaceuticals, Inc and Onyx Pharmaceuticals, Inc for the targeted agent Nexavar (sorafenib). The sNDA would include the use of Nexavar for the treatment of hepatocellular carcinoma (HCC). Mobile Mammography System Approved (9/7/2007) The United States Food and Drug Administration has approved GE Healthcare’s mobile mammography system, Senographe Essential. MGCD0103 Receives Orphan Drug Status (8/31/2007) The United States Food and Drug Administration (FDA) has granted orphan drug status to Pharmion and MethylGene’s agent MGCD0103. Marqibo Gets Fast-Track Designation (8/31/2007) Hana Biosciences has announced that their agent Marqibo has received fast-track designation by the United States Food and Drug Administration. FDA Approves Erbitux® Manufacturing Facility (8/28/2007) The United States Food and Drug Administration has approved ImClone System’ new facility to expand manufacturing of Erbitux (cetuximab). The second manufacturing facility of ImClone Systems for Erbitux is referred to as BB50 and will enhance abilities of the company to manufacture enough Erbitux to meet the increasing worldwide demand for the drug. Approvable Letter Received for Valstar® (8/28/2007) An approvable letter from the United States Food and Drug Administration (FDA) has been received by Indevus Pharmaceuticals, Inc for Valstar. NDA for Satraplatin Withdrawn (8/7/2007) GPC Biotech has withdrawn their new drug application (NDA) that was filed for satraplatin for the treatment of hormone-refractory prostate cancer. The NDA was withdrawn until results including overall survival can be obtained. At that time, the NDA will be resubmitted to the FDA. sBLA Accepted for Filing and Review for Cetuximab (Erbitux®) (8/3/2007) The United States Food and Drug Administration (FDA) has accepted for filing and review a supplemental biologics license application (sBLA) for ImClone Systems Incorporated’s targeted agent Erbitux (cetuximab). The sBLA is seeking the inclusion of improved overall survival in the product labeling for Erbitux when used as third-line treatment of metastatic colorectal cancer. GeneSearch™ BLN Approved for Detection of Breast Cancer Spread to Lymph Nodes (8/1/2007) The United States Food and Drug Administration (FDA) recently approved Veridex LLC’s (a Johnson and Johnson company) GeneSearch™ BLN Assay to detect whether breast cancer cells have spread to axillary lymph nodes. GeneSearch BLN Assay is the first molecular-based lab test to detect this stage of cancer. Priority Review Granted for Oral Formulation of Hycamtin® (7/31/2007) GlaxoSmithKline has received priority review status to its new drug application (NDA) for its chemotherapy agent Hycamtin (topotecan) for relapsed small cell lung cancer. ODAC Recommends Approval of Evista® for Breast Cancer Risk Reduction (7/27/2007) The Oncologic Drugs Advisory Committee (ODAC) of the U.S Food and Drug Administration (FDA) has recommended approval for Eli Lilly and Company’s drug Evista to reduce the risk of invasive breast cancer. ODAC recommended that the FDA approve Evista (raloxifene) for reducing the risk of invasive breast cancer in two groups of postmenopausal women: postmenopausal women with osteoporosis and postmenopausal women at high risk of breast cancer. Ixabepilone Granted Priority Review Status (7/26/2007) The United States Food and Drug Administration (FDA) has accepted, for filing and review, Bristol-Myers Squibbs’ New Drug Application (NDA) for their investigative agent ixabepilone for filing and review. The NDA has also been granted priority review status. Priority Review Status Denied for Cervarix™ (6/8/2007) The United States Food and Drug Administration (FDA) has declined to grant priority review status for Cervarix, GlaxoSmithKline’s (GSK) experimental vaccine. GSK had submitted its biologics license application (BLA) in March 2007. FDA Approves Torisel™ for Treatment of Advanced Renal Cell Carcinoma (6/6/2007) On March 30, 2007 the US Food and Drug Administration (FDA) approved Torisel (temsirolimus) for the treatment of advanced renal cell carcinoma (RCA). Doxil® Approved for Multiple Myeloma in Combination with Velcade® (5/24/2007) The US Food and Drug Administration (FDA) announced on May 17, 2007 the approval of Doxil (liposomal doxorubicin) plus Velcade for the treatment of patients with multiple myeloma who had failed at least one prior regimen and had not been treated with Velcade (vortezomib). Serum Lycopene Levels not Associated with Prostate Cancer (5/23/2007) Researchers involved in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial have reported that there is no association between serum lycopene levels and the risk of prostate cancer. The details of this study appeared in the May 1, 2007 issue of Cancer Epidemiology Biomarkers and Prevention. Provenge Followed by Taxotere May Improve Survival in Metastatic Prostate Cancer (5/23/2007) Researchers involved in 2 multicenter randomized trials have reported that Provenge® (Sipuleucel-T) may improve the survival of patients with asymptomatic metastatic androgen independent prostate cancer (AIPC) who received the vaccine followed by Taxotere® (docetaxel) at progression. The details of this study were presented at the 2007 annual meeting of the American Urological Association (AUA) in Anaheim, California. NDA Accepted for Xcytrin (5/7/2007) The United States Food and Drug Administration (FDA) has accepted the new drug application (NDA) submitted for Pharmacyclics’ new agent Xcytrin (motexafin gadolinium). Pharmacyclics is seeking approval for the use of Xcytrin in combination with radiation therapy for the treatment of patients with non-small cell lung cancer (NSCLC) and brain metastases. DepoCyt Gains Full Approval (5/4/2007) Full approval has been granted by the United States Food and Drug Administration (FDA) for Enzon Pharmaceuticals agent DepoCyt (cytarabine liposome injection) for the treatment of patients with lymphomatous meningitis. DepoCyt is a sustained-release formulation of the chemotherapy agent Cytarabine. Xyotax Granted Fast-Track Status (5/3/2007) Cell Therapeutics has been granted fast-track status for their agent Xyotax (paclitaxel poliglumex) for the initial treatment of women with advanced non-small cell lung cancer (NSCLC) who have a poor performance status. Priority Review Status Granted for Satraplatin (5/2/2007) The United States Food and Drug Administration (FDA) has accepted the new drug application (NDA) for GPC Biotech AG’s agent satraplatin and has granted priority review status for use as treatment in combination with prednisone in patients with hormone-refractory prostate cancer who have failed prior treatment with chemotherapy. sBLA Submitted for Gardasil® (4/30/2007) Merck has submitted a supplemental Biological license application (sBLA) for their cervical cancer vaccine Gardasil. The sBLA would include Gardasil to be used in the prevention in vaginal and vulvar cancers. FDA Extends NDA Review of Torisel™ (4/16/2007) The United States Food and Drug Administration (FDA) has announced that is has extended its review of Wyeth Pharmaceuticals’ New Drug Application (NDA) for its agent Torisel (temsirolimus) for the treatment of advanced renal cell carcinoma (RCC). Gardasil® Vaccination Guidelines Adopted by CDC (4/13/2007) The Centers for Disease Control (CDC) has adopted the unanimous recommendation of its Advisory Committee on Immunization Practices (ACIP) for Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) use in girls and women 11 to 26 years of age. Expanded Label Filed for Campath® (4/9/2007) Gemzyme Corporation and Bayer HealthCare have submitted a supplemental biologics license application (sBLA) for their agent Campath® (alemtuzumab) to the United States Food and Drug Administration (FDA). BLA Submitted for Cervarix® (4/3/2007) GlaxoSmithKline has submitted a Biologics License Application (BLA) to the United States Food and Drug Administration for their vaccine Cervarix. FDA Advisory Committee Recommends Approval for Provenge® (4/2/2007) The United States Food and Drug Administration’s (FDA) Office of Cellular, Tissue and Gene Therapies Advisory Committee recommended approval for Provenge (sipuleucel-T) for the treatment of patients with hormone refractory prostate cancer that is asymptomatic. sNDA Submitted for Xelox (3/30/2007) Roche has announced the submission of a supplemental new drug application (sNDA) to the United States Food and Drug Administration (FDA) for the use of XELOX (Xeloda® (capecitabine) plus Eloxatin® (oxaliplatin)) with or without Avastin® (bevacizumab) for the treatment of metastatic colorectal cancer. rNAPc2 Granted Fast-Track Status (3/29/2007) The United States Food and Drug Administration (FDA) has granted Nuvelo’s agent rNAPc2 fast-track designation for treatment of metastatic colorectal cancer. The designation specifies that rNAPc2 is to be used as initial therapy in addition to Avastin® (bevacizumab)-containing 5-flurouoracil-based chemotherapy regimens, or second-line therapy in addition to 5-fluorouracil-based chemotherapy regimens. SPA Agreement Reached for EOquin (3/16/2007) The United States Food and Drug Administration (FDA) and Spectrum Pharmaceuticals have reached a special protocol assessment (SPA) agreement for their drug EOquin (apaziquone for intravesical instillation). SPA Filed for Pixantrone in NHL (3/15/2007) Cell Therapeutics, Inc. has filed for a special protocol assessment (SPA) with the United States Food and Drug Administration (FDA) for their agent pixantrone for the treatment of relapsed indolent non-Hodgkin’s lymphoma (NHL). Tykerb® Approved for Advanced Breast Cancer (3/14/2007) The United States Food and Drug Administration (FDA) has approved the tyrosine kinase inhibitor Tykerb® (lapatinib) for the treatment of advanced breast cancer. The indication for Tykerb includes its use in combination with the chemotherapy agent Xeloda® (capecitabine) for the treatment of advanced or metastatic breast cancer in women whose cancer over expresses the human epidermal growth factor receptor 2 (HER2) and whose cancer has progressed following prior therapy with an anthracycline, a taxane, and Herceptin® (trastuzumab). New Guidelines on the Use of Procrit® and Ananesp® Released by the FDA (3/13/2007) The Food and Drug Administration (FDA) has released new guidelines on the use of epoetin alfa (Procrit®) and darbepoetin alfa (Ananesp®). Completion of New Drug Application Filing for Satraplatin (2/20/2007) Spectrum Pharmaceuticals announced completion of the filing of a new drug application (NDA) for their agent satraplatin in the treatment of hormone refractory prostate cancer (HRPC). Lumiliximab Granted Orphan Drug Status and Fast Track Status (2/9/2007) The United States Food and Drug Administration (FDA) has granted both orphan drug status and fast track status to Biogen Idec’s lumiliximab for the treatment of chronic lymphocytic leukemia (CLL). Investigational New Drug Application Filed for HIF-1 Alpha Antagonist (2/8/2007) The HIF-1 alpha antagonist is targeted against multiple cancer processes, as intracellular levels of the HIF-1 alpha protein are high compared to normal cells. Xanafide Gets Orphan Drug Designation (2/8/2007) The United States Food and Drug Administration (FDA) has granted Xanthus Pharmaceuticals’ orphan drug designation for their agent Xanafide (amonafide malate) for the treatment of acute myeloid leukemia (AML). MammaPrint® Approved to Predict Recurrences in Breast Cancer (2/7/2007) MammaPrint evaluates the activity of a panel of 70 genes from tumor tissue to produce a score that determines the likelihood of a patient’s recurrence (high-risk versus low-risk of recurrence). Investigational New Drug Accepted for Oral Formulation of Vidaza® (2/7/2007) Vidaza is already approved for subcutaneous administration and an IND has been accepted for the intravenous forms of administration of Vidaza. FDA Agrees to Review Supplemental New Drug Application for Doxil® Plus Velcade® in Multiple Myeloma (2/6/2007) The United States Food and Drug Administration (FDA) has agreed to review a supplemental new drug application (sNDA) for the combination of Doxil (pegylated doxorubicin HCl liposome injection) in combination with Velcade (bortezomib) for the treatment of relapsed or refractory multiple myeloma. IND Accepted for Breast Cancer Vaccine (2/5/2007) The United States Food and Drug Administration (FDA) has accepted BN ImmunoTherapeutics’ investigational new drug (IND) application for their breast cancer vaccine MVA-BN-HER2. Onconase® Granted Orphan Drug Status (2/5/2007) The United States Food and Drug Administration (FDA) has granted Alfacell Corporation orphan drug designation for their agent Onconase (ranpirnase) for the treatment of malignant mesothelioma. Intravenous Formulation of Vidaza® Approved (2/1/2007) The United States Food and Drug Administration (FDA) has approved an intravenous (IV) formulation of Pharmion’s Vidaza (azacitidine) in the treatment of myelodysplastic syndromes (MDS). Special Protocol Assessment Filed for Xyotax (2/1/2007) Cell Therapeutics has filed with the United States Food and Drug Administration (FDA) for a special protocol assessment (SPA) for the design of a phase III trial evaluating their investigative agent Xyotax. INNO-406 Granted Orphan Drug Status (1/26/2007) The United States Food and Drug Administration (FDA) has granted Innovive Pharmaceuticals orphan drug designation for the agent INNO-406 in the treatment of patients with chronic myelogenous leukemia who are either Gleevec-intolerant or Gleevec-resistant. Generic Versions of Zofran® Approved (1/26/2007) The approvals include generic versions of ondansetron tablets, orally disintegrating tablets and oral solution. Provenge® Granted Priority Review for Prostate Cancer (1/18/2007) The United States Food and Drug Administration (FDA) has granted priority review status to Dendreon Corporation’s Biologics License Application (BLA) for Provenge (sipuleucel-T). New Drug Application Submitted for Junovan (1/3/2007) IDM Pharma has submitted a new drug application (NDA) for approval of their agent Junovan (mifamurtide for injection) in the treatment of newly diagnosed, respectable high-grade osteosarcoma. Expanded Clearance for CellSearch™ System (1/2/2007) The United States Food and Drug Administration (FDA) has granted Veridex expanded clearance for CellSearch™ System to now be used as an aid in monitoring metastatic breast cancer. Eli Lilly Submits New Drug Application for Evista® (12/11/2006) Eli Lilly has submitted a new drug application (NDA) for Evista (raloxifene HCl) to reduce the risk of invasive breast cancer in postmenopausal women at a high risk for breast cancer. Velcade® Approved for Mantle Cell Lymphoma (12/11/2006) Millennium Pharmaceutical’s agent Velcade (bortezomib) was approved by the United States Food and Drug Administration (FDA) for the treatment of mantle cell lymphoma among patients who have received prior therapy. ClearPath™ Receives Marketing Clearance (11/21/2006) North American Scientific, Inc. has received 510(k) clearance from the United States Food and Drug Administration (FDA) for their breast brachytherapy product ClearPath. Herceptin® Approved as Adjuvant Therapy in Breast Cancer (11/17/2006) The new indication is for Herceptin to be used in combination with Adriamycin® (doxorubicin), cyclophosphamide and Taxol® (paclitaxel) for patients with node-positive localized breast cancer who have already received surgery with or without radiation therapy. Patients should be HER2-positive. BLA Submitted for Provenge® (11/15/2006) Dendreon has submitted the final portion of the biologics license application (BLA) to the U. S. Food and Drug Administration (FDA) for its immunotherapeutic agent Provenge (sipuleucel-T). Dendreon has also requested priority review designation for Provenge. Approvable Letter for Saforis for the Treatment and Prevention of Oral Mucositis (11/1/2006) MGI Pharma has received an approvable letter from the United States Food and Drug Administration (FDA) for their agent Saforis (glutamine) Powder in UpTec for Oral Suspension, for the prevention and treatment of oral mucositis. Gleevec® Approved for Five Disorders (10/26/2006) Novartis’ agent Gleevec (imatinib mesylate) has been approved by the United States Food and Drug Administration for the treatment of five rare and life-threatening diseases in which limited treatment options exist. Taxotere® Approved for Head and Neck Cancer (10/23/2006) The U.S. Food and Drug Administration (FDA) has approved Sanofi-Aventis' chemotherapy agent Taxotere (docetaxel) to be used in combination with Platinol(R) (cisplatin) and 5-FU (fluorouracil) as induction therapy for inoperable, locally advanced squamous cell carcinoma of the head and neck. Avastin® Approved for Initial Therapy of NSCLC (10/18/2006) Genentech has received approval from the United States Food and Drug Administration (FDA) to market Avastin (bevacizumab), in combination with Taxol(paclitaxel) and Paraplatin (carboplatin), as initial therapy for locally advanced, metastatic, recurrent or unresectable non-small cell lung cancer. FDA Approves Zolinza™ for Treatment of Cutaneous T-Cell Lymphoma (10/12/2006) On October 6, 2006, the U.S. Food and Drug Administration approved Zolinza (vorinostat) for the treatment of the cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in patients with progressive, persistent, or recurrent disease following two systemic therapies. Rituxan® Approved for Two New Indications (10/3/2006) Genentech and Biogen Idec’s agent Rituxan (rituximab) has received approval for two new indications by the United States Food and Drug Administration (FDA). FDA Approves Gleevec® for Pediatric CML (10/2/2006) Approval was based on the treatment of 51 pediatric patients with newly diagnosed CML enrolled in a phase II clinical trial. Vectibix™ (Panitumumab) Approved for Recurrent Colorectal Cancer (9/29/2006) Vectibix is the first entirely humanized monoclonal antibody targeting the epidermal growth factor receptor (EGFR). Majority of ODAC Does Not Recommend Genasense® For Treatment of CLL (9/18/2006) The majority of the United States Food and Drug Administration’s advisory committee ODAC (Oncologic Drugs Advisory Committee) has voted to not recommend Genasense (oblimersen sodium) for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL). Exelixis Submits Investigational New Drug Application for XL228 (9/15/2006) Exelixis has submitted an investigational new drug (IND) application for its agent XL228 to the United States Food and Drug Administration (FDA). FDA Requests Safety and Efficacy Updates for Avastin® (9/15/2006) The United States Food and Drug Administration (FDA) has requested, from Genentech, Inc., substantial safety and efficacy updates from the E2100 trial evaluating Avastin (bevacizumb) in the treatment of metastatic breast cancer. Investigational New Drug Filed for MT103 (9/1/2006) The indication was filed for the treatment of B-cell non-Hodgkins lymphoma (NHL) among patients who are not eligible for curative therapy. Partial Biologics License Application Filed for Provenge® (8/31/2006) The indication is for the treatment of metastatic, androgen-independent prostate cancer among asymptomatic patients. New Drug Application Submitted for Zensana® Oral Spray (8/31/2006) Hana has submitted a new drug application (NDA) for Zensana (ondansetron HCI) oral spray. The indication is for the prevention of nausea and vomiting associated with chemotherapy and radiation therapy. Allowance for Investigational New Drug Application for MDX-1106/ONO-4538 (8/25/2006) MDX-1106/ONO-4538 is a fully human antibody that is designed to activate T-cell responses against cancer and promote immune response. Orphan Drug Status Granted to PDX (8/21/2006) PDX causes its anti-cancer effects by inhibition of an enzyme involved in the formation of DNA. NOV-002 Receives Fast-Track Designation for the Treatment of Lung Cancer (8/17/2006) The indication granted within the fast-track designation includes the use of NOV-002 to be used in combination with first-line chemotherapy for advanced non-small cell lung cancer (NSCLC). Calypso® 4D Localization System Gets 510 (k) Clearance (8/17/2006) The Calypso 4D localization system is designed to provide continuous location information of a tumor during external beam radiation therapy without the addition of ionizing radiation. Dacogen® (Decitabine) Granted Orphan Drug Status for Leukemia (8/15/2006) Dacogen has been already approved for the treatment of myelodysplastic syndromes (MDS). The approval included the treatment of patients with previously treated or untreated MDS, including de novo and secondary MDS of all FAB subtypes. Velcade® (Bortezomib) Granted Priority Review for Mantle Cell Lymphoma (8/15/2006) The priority review designation is in reference to the supplemental new drug application submitted by Millennium Pharmaceuticals, Inc. for this indication. Panzem Gets Orphan Drug Status for Glioblastoma Multiforme (7/28/2006) The designation of orphan drug status was based on in vitro studies that demonstrated anti-proliferative activity against glioma cell lines, and anti-tumor activity in in vivo studies involving a preclinical model of glioblastoma. FDA Approves Oncaspar® for Treatment of Newly Diagnosed ALL (7/26/2006) The U.S. Food and Drug Administration (FDA) approved use of Oncaspar (pegylated L-asparaginase) in children and adults with newly diagnosed acute lymphoblastic leukemia (ALL) in combination with other chemotherapy drugs. FDA Approves New Over-the-Counter Sunscreen Product (7/26/2006) The U.S. Food and Drug Administration (FDA) today approved Anthelios SX, a sunscreen to be sold over-the-counter (OTC) for the prevention of sunburn and for protection against ultraviolet B (UVB) and ultraviolet A (UVA) rays. It has a sun protection factor (SPF) of 15. Gemzar® Approved for Recurrent Ovarian Cancer (7/19/2006) The United States Food and Drug Administration (FDA) has just approved Gemzar® (gemcitabine) for the treatment of recurrent ovarian cancer. The approved indication includes the use of Gemzar in combination with Paraplatin® (carboplatin) in patients whose cancer has returned or progressed at least six months following prior treatment. FDA Approves Revlimid® for Treatment of Multiple Myeloma (7/3/2006) According to the American Society of Hematology, the U.S. Food and Drug Administration (FDA) announced June 29, 2006, the approval of oral Revlimid (lenalidomide) for the treatment of patients with multiple myeloma who have failed one prior treatment. FDA Approves Dasatinib (Sprycel®) for Chronic Myeloid Leukemia (6/30/2006) On June 29, 2006, the U.S. Food and Drug Administration (FDA) announced the approval of dasatinib for the treatment of patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (ALL) who are resistant to or intolerant of Gleevec® (imatinib mesylate). MORAb-003 Receives Orphan Drug Status for Ovarian Cancer (6/29/2006) MORAb-003 is a human IgG1 antibody that recognizes GP-3 – a cell surface glycoprotein that is overexpressed in several types of epithelial-derived cancers. Special Protocol Assessment for Ipilimumab in Melanoma (6/28/2006) Medarex, Inc. has received a Special Protocol Assessment (SPA) for the initiation of a registrational clinical trial evaluating ipilimumab (MDX-010) for use as first-line treatment, in combination with dacarbazine, for metastatic melanoma. Investigational New Drug Application Filed for LP-261 (6/28/2006) LP-261 is a small-molecule oral drug that has been designed to block tumor growth. The phase I trial will be evaluating LP-261 in patients with hematologic malignancies and advanced solid tumors. Special Protocol Assessment Granted for Bexidem (6/27/2006) IDM Pharma has received a special protocol assessment (SPA) from the U.S. FDA for their investigative agent Bexidem in the treatment of superficial bladder cancer. Fast-Track Status Granted to MyVax® for Follicular NHL (6/23/2006) MyVax is a patient-specific active immunotherapy agent. Nexavar® Granted Fast-Track Status for Metastatic Hepatocellular Carcinoma (6/23/2006) Nexavar is a multi-kinase inhibitor targeting both tumor cell and tumor vasculature. It is an oral agent that is targeted against kinases involved in cellular proliferation as well as angiogenesis. Avastin® Approved for Recurrent Colorectal Cancer (6/22/2006) The U.S. Food and Drug Administration (FDA) has approved the use of Avastin (bevacizumab), in combination with 5-fluorouracil (5-FU)-based chemotherapy for the treatment of advanced colorectal cancer in patients who have received a prior therapeutic regimen. Avastin is already approved for use as initial treatment in combination with 5-FU-based chemotherapy in patients with advanced colorectal cancer. Hycamtin® Approved for Advanced Cervical Cancer (6/22/2006) GlaxoSmithKline’s chemotherapy agent Hycamtin (topotecan) has received FDA approval for an expanded indication to include treatment of recurrent cervical cancer in combination with Platinol® (cisplatin). Biologic License Application Accepted and Priority Review Granted for Panitumumab (6/14/2006) The BLA submitted for panitumumab was for the treatment of metastatic colorectal cancer among patients who have failed prior chemotherapy, including Eloxatin® (oxaliplatin) and/or Camptosar® (irinotecan)-based regimens. U.S. FDA Approves Gardasil® (6/8/2006) The United States Food and Drug Administration (FDA) has approved Merck & Co., Inc.’s vaccine Gardasil (Quadrivalant Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine) for the prevention of cervical cancer. Advisory Committee Unanimously Recommends Approval of Sprycel for Gleevec®-Resistant CML (6/8/2006) The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) unanimous recommended approval of Bristol-Myers Squibb’s agent Sprycel (dasatinib) for Gleevec (imatinib)-refractory or Gleevec-intolerant chronic myelogenous leukemia (CML). FDA Grants Fast-Track Status to Urocidin™ (6/2/2006) Urocidin, or Mycobacterial Cell Wall-DNA Complex (MCC), is a formulation from Mycobacterium phlei, which is a non-pathogenic strain of mycobacteria. It has demonstrated immune stimulatory properties and apoptotic activity against cancer cells. Amphotericin B Inhalation Powder Gets Fast-Track Status (6/2/2006) Nektar Therapeutics has received fast-track designation for its agent Amphotericin B Inhalation Powder (ABIP) for the prevention of fungal infection of the lung in at-risk patients. Talotrexin Granted Orphan Drug Status for Acute Lymphoblastic Leukemia (5/30/2006) Talotrexin is a nonpolyglutamatable antifolate agent. It is currently in a multicenter phase I/II trial being evaluated in the treatment of relapsed or refractory ALL. Thalomid® Approved for Initial Treatment of Multiple Myeloma (5/26/2006) Thalomid has been previously approved for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence in July 1998. Supplemental Biologics License Application for Avastin® in Lung Cancer Submitted (5/25/2006) Genentech, Inc. has submitted a supplemental biologics license application (sBLA) for use of Avastin (bevacizumab), in combination with platinum-based therapy, for initial treatment of advanced non-squamous, non-small cell lung cancer (NSCLC). Genetech Files sBLA for Avastin in Breast Cancer (5/25/2006) Avastin is an antibody that is targeted against the vascular endothelial growth factor (VEGF). Combretastatin A4P Gets Second Orphan Drug Designation (5/24/2006) The United States Food and Drug Administration (FDA) has granted OXiGENE orphan-drug status for their agent Combretastatin A4P (CA4P) in the treatment of ovarian cancer. IND Approved for SVV-001 (5/24/2006) Upon IND approval, a phase I, dose-escalating clinical trial will evaluate SVV-001 in the treatment of certain types of advanced neuroendocrine cancers. FDA Advisory Committee Supports Gardasil® (5/19/2006) The United States Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee has voted unanimously that Merck & Co., Inc.’s vaccine Gardasil (quadrivalent human papillomavirus recombinant vaccine) is safe and effective for the prevention of cervical cancer and the prevention of cervical, vulvar and vaginal pre-cancers caused by the human papillomavirus (HPV) types 16 and 18 in females. FDA Grants Marketing Approval for Cesamet® (5/19/2006) Casemet, an oral agent, has been cleared to be marketed for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have not responded to standard anti-emetic therapies. Fast-Track Status for BioVaxID (5/18/2006) BioVaxID utilizes idiotypes from a patient’s cancer cells which are ultimately conjugated to an immune stimulant in the form of a vaccine. Chantix® Approved for Smoking Cessation (5/18/2006) Pfizer’s smoking-cessation drug Chantix (varenicline tartrate), has been approved by the United States Food and Drug Administration (FDA). Special Protocol Assessment Granted for TroVax (5/18/2006) Trovax is a vaccine comprising the tumor-associated antigen 5T4 that is delivered using a pox virus vector. Investigational New Drug Application Approved for Vioquest’s VQD-002 (5/15/2006) The U.S. Food and Drug Administration (FDA) has accepted Vioquests’s investigational new drug (IND) application for its agent VQD-002 (triciribine-phosphate). New Drug Application to Be Submitted for Xcytrin® (5/10/2006) The NDA will include the indication for the treatment of non-small cell lung cancer (NSCLC) in patients with brain metastases. GVAX Granted Fast-Track Designation for Prostate Cancer (5/10/2006) GVAX immunotherapies for prostate cancer comprise whole-cell products from two prostate cancer cell lines. The cells have been modified so they secrete granulocyte-macrophage colony stimulating factor (GM-CSF). Nexavar® Granted Orphan Drug Status for Hepatocellular Carcinoma (5/4/2006) The U.S. Food and Drug Administration (FDA) has granted Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. orphan drug status for their agent Nexavar® (sorafenib) in the treatment of hepatocellular carcinoma (HDCC). IND Approved for AT9283 (5/4/2006) Astex Therapeutics has been granted approval from the U.S. Food and Drug Administration (FDA) for their Investigational New Drug (IND) application for their aurora kinase inhibitor AT9283 in the treatment of cancer. FDA Requests More Information for Hexvix® NDA (5/4/2006) The United States Food and Drug Administration (FDA) has requested more information to PhotoCure ASA regarding the new drug application (NDA) for their agent Hexvix® (hexaminolevulinate). Dacogen™ Approved for MDS (5/4/2006) MGI Pharma and SuperGen have received approval for their agent Dacogen™ (decitabine) in the treatment of myelodysplastic syndromes (MDS). Supplemental Biologics License Application Submitted for Avastin® in Lung Cancer (4/19/2006) Genentech, Inc. has submitted a supplemental biologics license application (sBLA) for the use of Avastin (bevacizumab) in combination with platinum-based therapy for initial treatment of advanced non-squamous, non-small cell lung cancer (NSCLC). IND Submitted for Cytogen Corporation’s Prostate Cancer Agent (4/18/2006) Cytogen Corporation has submitted an Investigational New Drug (IND) application for their agent CYT-500 in the treatment of hormone-refractory prostate cancer. Dose Verification System Cleared for Market (4/18/2006) Sicel Technologies, Inc. has received clearance from the Food and Drug Administration (FDA) to market its Dose Verification System to measure the amount of radiation reaching a tumor in patients with cancer. Orphan Drug Status for Lestaurtinib (4/6/2006) The orphan drug designation is for treatment of acute myeloid leukemia (AML). SBLA Submitted for Rituxan® as Initial Therapy in Low-Grade or Follicular NHL (4/6/2006) Rituxan is a monoclonal antibody targeted against the CD20 antigen and is currently approved for the treatment of relapsed or refractory low-grade follicular CD20+ B-cell NHL, and as first-line therapy for diffuse large B-cell, CD20+ NHL to be used in combination with CHOP or other anthracycline-based chemotherapy. BLA Submitted for Panitumumab (4/3/2006) The potential indication for panitumumab is for the treatment of patients with metastatic colorectal cancer who have failed previous treatment with chemotherapy, including Eloxatin® (oxaliplatin) and Camptosar® (irinotecan)-containing regimens. OsmoPrep™ Approved for Colonoscopy Preparation (3/30/2006) Salix Pharmaceuticals’ drug OsmoPrep (sodium phosphate monobasic monohydrate/sodium phosphate dibasic anhydrous) tablets have been approved as a colon-cleansing drug for use in the preparation of a colonoscopy procedure in individuals 18 years or older. Orphan-Drug Status Granted to Zadaxin® (3/28/2006) SciClone Pharmaceuticals, Inc.’s Zadaxin® (thymalfasin) has been granted orphan-drug designation from the U.S. Food and Drug Administration. Aranesp® Approved for Every Three-Week Dosing (3/28/2006) Amgen’s Aranesp (darbepoetin alfa) has recently been approved for every three-week dosing in the treatment of chemotherapy-induced anemia in non-myeloid malignancies. Aranesp was previously approved for once-weekly dosing. Taxotere® Approved for Advanced Gastric Cancer (3/24/2006) Sanofi-Adventis has recently received FDA approval for Taxotere (docetaxel) in the treatment of advanced gastric cancer. The indication includes Taxotere to be used in combination with 5-fluorouracil and cisplatin (Platinol®) in the treatment of previously untreated, advanced gastric cancer, including cancer of the gastro-esophageal (GE) junction. ODAC Review Not Positive for Gemzar® in the Treatment of Relapsed Ovarian Cancer (3/14/2006) ODAC stated that although the addition of Gemzar to carboplatin improved progression-free survival by 2.8 months compared to carboplatin alone in patients with relapsed ovarian cancer, toxicity was significantly increased with the addition of Gemzar with no apparent benefit for survival. Priority Review Granted for Revlimid® in Relapsed Multiple Myeloma (3/3/2006) The supplemental new drug application (sNDA) that was submitted is for the use of Revlimid in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy. Investigational New Drug Application Filed for D93 (3/2/2006) D93 is a humanized monoclonal antibody that selectively targets specific molecules in the extracellular matrix of a cell. Erbitux® Approved for Treatment of Head and Neck Cancer (3/2/2006) The new indication includes the use of Erbitux in combination with radiation therapy for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck, or as a single agent in the treatment of metastatic or recurrence squamous cell carcinoma of the head and neck that has failed prior platinum-based therapy. Supplemental New Drug Application Accepted for Hycamtin® in Treatment of Cervical Cancer (2/21/2006) The sNDA seeks marketing for Hycamtin used in combination with Platinol® (cisplatin) for the treatment of stage IVB cervical cancer that is recurrent or persistent and not considered curable with surgery and/or radiation therapy. Submission of sBLA Completed for Use of Herceptin® in the Adjuvant Setting of Breast Cancer (2/16/2006) The sBLA is based on results from the two phase III trials randomized trials conducted by the NSABP and the NCCTG. Tesmilifene Gets Fast-Track Status for Breast Cancer (2/16/2006) The indication is for the treatment of advanced breast cancer to be used in combination with an anthracycline-based regimen. NeoGuide Systems Computer-Assisted Colonoscopy System Cleared for Marketing (2/16/2006) This system is intended to eliminate looping and enhance physician control over conventional colonoscopy procedures. FDA Approves Rituxan® for First-Line Treatment of Diffuse Large B-Cell Lymphoma (2/14/2006) The approval of up-front Rituxan in DLBCL was based on three randomized controlled trials (E4495, LNF 98-5/GELA and M39045/MiNT). These three trials enrolled almost 2,000 patients with predominantly stage III-IV disease. Propera® SurTRAK Brachytherapy Approved for Prostate Cancer (2/10/2006) Launch of the new product is expected February 2006. Xyotax Gains Fast-Track Designation (2/9/2006) Cell Therapeutics, Inc.’s Xyotax (paclitaxel poliglumex) has received fast-track designation from the United States Food and Drug Administration (FDA) for the treatment of poor performance status (PS2) women with advanced non-small cell lung cancer (NSCLC) who have not received prior therapy. Maribavir Granted Fast-Track Status (2/8/2006) The agent is being investigated for the prevention of cytomegalovirus (CMV) in allogeneic bone marrow or stem cell transplantation, as well as solid organ transplants. Gardasil® Receives Priority Review (2/7/2006) Gardasil is a vaccine that is protective against the human papillomavirus (HPV) types 16, 18, 6 and 11. Types 16 and 18 account for approximately 70% of cervical cancer cases and types 6 and 11 account for approximately 90% of genital warts. Sutent® Approved for Gastrointestinal Stromal Tumors and Advanced Renal Cell Carcinoma (2/3/2006) This is first time the FDA has simultaneously approved one drug with two indications for oncology purposes. Zactima™ Gets Fast-Track Status for Thyroid Cancer (2/2/2006) Zactima has previously been granted orphan-drug designation for the treatment of follicular, medullary, anaplastic, and locally advanced and metastatic papillary thyroid cancer. Misonix Approved as Surgical Tool (2/1/2006) The Sonatherm System utilizes High Intensity Focused Ultrasound (HIFU) technology licensed from Focus Surgery for ablation of certain soft tissue lesions in general surgery procedures. Sutent® Approved for Kidney Cancer (2/1/2006) The United States Food and Drugs Administration (FDA) has approved the new targeted agent Sutent (sunitinib malate) for treatment of advanced renal cell carcinoma (RCC). Axxent™ Electronic Brachytherapy Cleared for Treatment of Breast Cancer (1/19/2006) Electronic brachytherapy “is a proprietary technology platform designed to deliver localized, non-radioactive, isotope-free radiation treatment in a minimally-shielded clinical setting under the supervision of a radiation oncologist.” FavId® Receives Fast Track Designation for Follicular Lymphoma (1/19/2006) FavId is an agent that utilizes idiotype proteins obtained from a patient’s tumor. The proteins are combined with immune stimulating agent, keyhold limpet hemocyanin (KLH). Sodium Iodide I-131 Capsules Approved for Diagnostics (1/17/2006) The indication allows the capsules to be used “to perform the radioactive iodide (RAI) uptake test to evaluate thyroid function prior to treatment with stronger radiation doses of therapy including the agent.” Indication for Ethyol® Withdrawn (1/12/2006) The withdrawn indication was for the use of Ethyol “to reduce the cumulative renal toxicity associated with repeat administration of cisplatin in patients with non-small cell lung cancer (NSCLC).” Additional Indication for Emend® Granted (1/11/2006) Emend is now indicated, with other antiemetic agents, for the prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy. Fast Track Status for Genmab’s HuMax-EGFr (1/9/2006) The designation includes the use of HuMax-EGFr in the treatment of head and neck cancer that has progressed or recurred following prior therapies. Investigational New Drug Submitted for CRS-100 (1/9/2006) The application is for the initation of a phase 1 safety trial of CRS-100 for the treatment of cancer patients with liver metastasis. FDA Approves Revlimid™ for the Treatment of MDS (1/5/2006) On December 27, 2005, the US Food and Drug Administration (FDA) approved oral Revlimid (lenalidomide) for the treatment of transfusion-dependent anemia due to low or intermediate risk myelodysplastic syndrome (MDS) that is associated with deletion 5q cytogenetic abnormality.[ NDA Filed for Genasense® (12/29/2005) A New Drug Application (NDA) has been filed for Genta Incorporated’s leading anticancer agent Genasense® (oblimersen sodium) Injection. Rolling Submission of NDA for Dasatinib Completed (12/29/2005) Bristol-Myers Squibb Company has completed the rolling submission of its New Drug Application (NDA) for dasatinib to the United States Food and Drug Administration (FDA). Femara® Approved for Initial Adjuvant Therapy in Postmenopausal Women (12/29/2005) The United States Food and Drug Administration (FDA) had granted Novartis approval for their aromatase agent Femara® (letrozole) to be used as initial adjuvant therapy in postmenopausal women with hormone-positive breast cancer. Revlimid® Approved for Myelodysplastic Syndromes (12/28/2005) Celgene Corporation has announced that the U.S. Food and Drug Administration has approved Revlimid® (lenalidomide) for the treatment of low to intermediate risk-1 myelodysplastic syndromes (MDS) in patients who are transfusion-dependent associated with a 5q cytogenetic abnormality, with or without other cytogenetic abnormalities. sBLA Submitted for Avastin® (12/22/2005) Genetech has submitted a supplemental biologics license application (sBLA) for Avastin (bevacizumab) to be used in the treatment of relapsed, metastatic colorectal cancer. Investigational New Drug Application Filed for TNX-650 (12/22/2005) TNX-650 is a monoclonal antibody that is specifically targeting interleukin 13. The new application would include TNX-650 for the treatment of refractory Hodgkin’s lymphoma. Nexavar® Approved by the FDA for Renal Cell Carcinoma (12/22/2005) Bayer Phaarmaceuticals Corporation and Onyx Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Nexavar (sorafenib) tablets for the treatment of advanced renal cell carcinoma on December 20, 2005. Orphan Drug Status Granted to Prochymal™ (12/21/2005) Orphan Drug Status has been granted by the United States Food and Drug Administration (FDA) to Osiris Therapeutics, Inc. for their agent Prochymal for the treatment of graft-versus-host-disease (GVHD). Rolling New Drug Application Submission Begins for Satraplatin (12/21/2005) The NDA is for the use of satraplatin in combination with prednisone for hormone-refractory prostate cancer as second-line chemotherapy. Approvable Letter for Resubmission of Dacogen™ (12/21/2005) The U.S. Food and Drug Administration (FDA) has accepted MGI Pharma and SuperGen, Inc.’s resubmission as a complete response to the Approvable Letter for Dacogen (decitabine) for myelodysplastic syndromes (MDS). Merck Submits BLA for Gardasil® (12/13/2005) Merck & Co, Inc. has announced that it has submitted a Biologics License Application (BLA) for their investigational vaccine for cervical cancer Gardasil (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) to the U.S. Food and Drug Administration. Priority Review Granted for Taxotere® sNDA (12/6/2005) The sNDA application was for the use of Taxotere in combination with Platinol® (cisplatin) and Adrucil® (5-fluorouracil) in the treatment of advanced gastric cancer. IND Granted to Adherex’s Eniluracil (11/30/2005) The company states that eniluracil enhances the effectiveness of 5-fluorouracil, if doses and ratios between the two drugs are used appropriately. |