Advisory Committee Recommends FDA Wait for Satraplatin Survival Results

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Article
OncologyONCOLOGY Vol 21 No 9
Volume 21
Issue 9

GPC Biotech announced that the Oncologic Drugs Advisory Committee (ODAC) for the US Food and Drug Administration (FDA) recommended (12–0) that the FDA should wait for the final survival analysis of the SPARC trial before deciding whether satraplatin is approvable for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed.

GPC Biotech announced that the Oncologic Drugs Advisory Committee (ODAC) for the US Food and Drug Administration (FDA) recommended (12–0) that the FDA should wait for the final survival analysis of the SPARC trial before deciding whether satraplatin is approvable for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed.

As a result, GPC Biotech has withdrawn its New Drug Application for accelerated approval of the drug. The company anticipates overall survival results to be available within 6 months.

Articles in this issue
Updated Study Results Reinforce Survival Benefit of Docetaxel for Men With Advanced, Hormone-Resistant Prostate Cancer
Gene Variations Directly Link Inflammation to an Increased Risk for Lung Cancer
ODAC Recommends Approval of Raloxifene to Reduce Risk of Invasive Breast Cancer
Liposomal Doxorubicin Delays Time to Disease Progression as Maintenance Therapy in Patients With Metastatic Breast Cancer
Advisory Committee Recommends FDA Wait for Satraplatin Survival Results
New Complementary Medicine Guidelines Available From Society of Integrative Oncology
Skin Rash Actually Signifies Better Outcomes for Pancreatic and Lung Cancer Patients
Red Wine Protects the Prostate, Seattle Investigators Report
Lenalidomide Data in Multiple Myeloma Patients Demonstrate Impressive Survival Benefit
Key Developments in Rectal Cancer Treatment
Role of Stem Cell Transplant in Pediatric Cancers
Curing Gastric Cancer: Steps in the Right Direction But Miles to Go
Hepatocellular Carcinoma: Neoadjuvant Therapy Reconsidered
Integrins in Cancer: Novel Therapeutic Approaches
Honing Therapy for Rectal Cancer
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