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.
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.