Merck, Roche and Bristol Myers nab 4 of 6 positive ODAC votes for ‘dangling’ accelerated approvals

What looked at the outset like a prime opportunity for the FDA to critique industry over failed confirmatory trials for lagging accelerated approvals ended up being mostly a triumph for the large biopharma companies.

The FDA’s Oncologic Drugs Advisory Committee voted in favor of keeping on the market four of the six “dangling” accelerated approvals presented to it over the last three days. Even despite the failed trials, companies and their physicians raised concerns about unmet treatment needs and the long duration of responses for the checkpoint inhibitors before each of the six votes.