ARTICLE | Regulation

Will FDA change the accelerated approval paradigm for cancer?

ODAC meeting poses challenges for FDA

May 1, 2021 1:35 AM UTC

The integrity of the accelerated approval pathway was on trial at the April 27-29 meeting of FDA’s Oncologic Drugs Advisory Committee, but the verdict won’t be clear until the agency announces and describes the actions it will take on the six accelerated approvals for checkpoint inhibitors that were discussed at the meeting.

The most important question is whether the meeting outcomes will prompt FDA to revise the paradigm for accelerated approval of cancer therapies. ...