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.
The two ODAC votes that didn’t receive a majority of “yes” votes from the outside experts were Merck’s Keytruda (pembrolizumab) as a third-line treatment for stomach cancer and Bristol Myers Squibb’s Opdivo (nivolumab) as a second line treatment for liver cancer. In both cases, Richard Pazdur, director of the FDA’s Oncology Center of Excellence, raised concerns with the committee, while noting the unintended consequences of keeping Keytruda on the market and questioning BMS data (see more below).
Overall, however, the main takeaway from the last three days is that if you’re a biopharma company that has won an…