ODAC meeting on checkpoint inhibitors could affect future of accelerated approval

The integrity and future of FDA’s accelerated approval pathway will be on trial at next week’s Oncologic Drugs Advisory Committee meeting.

ODAC will be making recommendations about retaining or withdrawing six accelerated approvals for three PD-1 and PD-L1 inhibitors (see table at end), but the deliberations could have consequences that go well beyond the fates of the specific drugs, the patients diagnosed with the indications and the therapies’ manufacturers. ...