Trials & Filings

BMS Gets FDA Priority Review For Opdivo

FDA previously granted the kidney cancer drug breakthrough therapy designation for renal cell carcinoma

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Bristol-Myers Squibb said that the U.S. Food and Drug Administration (FDA) has accepted for filing and priority review a supplemental biologics license application (sBLA) for Opdivo for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. The FDA previously granted Opdivo breakthrough therapy designation for this indication, underscoring the critical need for new treatment options for patients with advanced RCC who have received prio...

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