FDA Considers Approval of Fusilev for Colorectal Cancer
The FDA has notified Spectrum Pharmaceuticals that it will decide whether to approve Fusilev (levoleucovorin) for colorectal cancer within 6 months.
The FDA has notified Spectrum Pharmaceuticals that it will decide whether to approve Fusilev (levoleucovorin) for colorectal cancer within 6 months. The current indications for Fusilev include osteosarcoma and methotrexate-related toxicity. In October 2009, the FDA rejected a request to approve Fusilev for colorectal cancer based on lack of efficacy. The manufacturer submitted additional data in support of its application to the FDA on October 29, 2010.
Articles in this issue
Medulloblastoma Subtypes Are Different Diseases
ASH 2010: CPX-351 Improves Response in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
ASH 2010: Elotuzumab Highly Active in Patients With Advanced Myeloma
ASH 2010: Intensified R-ACVBP More Effective and More Toxic Than R-CHOP in Diffuse Large B-Cell Lymphoma
ASH 2010: Carfilzomib Shrinks Tumors in More Than One-Third of Pretreated Myeloma Patients
ASH 2010: Brentuximab Vedotin Produces High Response Rate in Relapsed or Refractory Hodgkin Lymphoma
ASH 2010: Bosutinib Shows Promise as First-line Treatment of Chronic Myelogenous Leukemia
ASH 2010: Multiple Benefits Observed for Bortezomib in Newly Diagnosed Myeloma Patients
FDA Green-Lights Phase III Trial for Drug-Eluting Microspheres in Liver Cancer
FDA Requests Label Change for Generic Docetaxel
FDA Considers Approval of Fusilev for Colorectal Cancer
Advisory Panel Discusses Expanded Indication for Avodart
FDA Approves Zactima
Effects of UV Radiation Are Cumulative
People in Britain Say Find Aliens, Cure Cancer
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