FDA can­cels ODAC meet­ing this week as Se­cu­ra Bio pulls ac­cel­er­at­ed ap­proval

The FDA’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee has de­cid­ed to can­cel a planned meet­ing on Thurs­day to dis­cuss two can­cer drugs that pre­vi­ous­ly won ac­cel­er­at­ed ap­provals but failed to con­firm clin­i­cal ben­e­fit in re­quired fol­low-up tri­als or have tak­en a long time to fin­ish those tri­als.

Se­cu­ra Bio said late Tues­day af­ter­noon that it’s de­cid­ed to pull its third-line mul­ti­ple myelo­ma drug Fary­dak, first ap­proved un­der the ac­cel­er­at­ed path­way in 2015.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.