BioCentury
ARTICLE | Regulation

FDA cancels ODAC meeting on two accelerated approvals

Decision may be last stop on regulatory ride for Farydak and Marqibo 

December 1, 2021 2:44 AM UTC

Farydak and Marqibo have ridden regulatory roller coasters in the U.S., but after FDA canceled a Dec. 2 ODAC meeting to review the status and results of confirmatory trials for the two cancer drugs, which have accelerated approval, the therapies may have seen their last ride.

The meeting of the agency’s Oncologic Drugs Advisory Committee to discuss Marqibo vincristine and Farydak panobinostat is no longer needed, an FDA spokesperson told BioCentury. The agency declined to elaborate. ...