Accelerated Approval: US FDA Panel To Reconsider Six Indications For Checkpoint Inhibitors

The US Food and Drug Administration’s extensive use of accelerated approval for checkpoint inhibitors will be on the line next month when an advisory committee weighs the future of six indications under the expedited pathway for three cancer immunotherapies that have failed to confirm clinical benefit.

The Oncologic Drugs Advisory Committee will meet 27-29 April to discuss whether to keep on label or withdraw: two indications for Genentech, Inc.’s PD-L1 inhibitor Tecentriq (atezolizumab); three for Merck & Co., Inc.’s PD-1 inhibitor Keytruda (pembrolizumab); and one for Bristol Myers Squibb Company’s PD-1 inhibitor Opdivo (nivolumab)