The ABCs Of Accelerated Approval Withdrawals
At least six accelerated approval drugs have either been withdrawn or had indications revoked because confirmatory studies were not completed or failed to verify clinical benefit – including Avastin, Bexxar and Celebrex.
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The latest drug development news and highlights from our US FDA Performance Tracker.
EMD Serono had not marketed the infertility treatment in US since 2012, when it first asked FDA to withdraw application; company was unable to complete confirmatory trial required under accelerated approval.
Under questioning from FDA’s Richard Pazdur, VP Sandra Horning says company would be willing to withdraw pertuzumab’s neoadjuvant indication if results from ongoing adjuvant study are “clearly negative”; advisory committee members say they expect sponsor to bow out more gracefully than it did in the fight over bevacizumab’s breast cancer claim.