Immunotherapy Withdrawals Put Spotlight on Accelerated Approval
Elie Dolgin • June 1, 2021
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.
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