Immunotherapy Withdrawals Put Spotlight on Accelerated Approval.

Abstract

The FDA s Accelerated Approval program is under scrutiny after four drug companies announced plans in recent months to withdraw indications for checkpoint inhibitors that, despite showing early promise, failed to demonstrate a survival benefit in confirmatory trials. The agency s Oncologic Drugs Advisory Committee will meet in late April to discuss whether six more indications for some of these same immunotherapies should be nullified as well.