BMS Evaluating Duration Of Neurotoxicity With Taxol Three-Hour Infusion
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Approval of Bristol-Myers Squibb’s Taxol as a three-hour infusion for first-line treatment of ovarian cancer is contingent on a Phase IV commitment to evaluate "the duration of neurotoxicity when Taxol is given as a three-hour infusion in combination with a platinum," FDA said in its approval letter for the combination regimen.
You may also be interested in...
FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011
September 2010 Approvals
Product
Provenge Paradox Sparks New Thinking About Immunotherapy Trials, Clinical Care
The paradoxical finding that Dendreon's cancer immunotherapeutic Provenge (sipuleucel-T) improved overall survival in men with metastatic castration-resistant prostate cancer but did not appear to slow the progression of the disease is raising questions about the future of clinical development for the burgeoning class