BMS racks up another Opdivo approval after FDA makes quick decision

BMS Chairman Lamberto Andreotti

Bristol-Myers Squibb ($BMY) has won yet another approval for its pioneering immuno-oncology drug Opdivo. The regulatory nod in advanced renal cell carcinoma (RCC), a form of kidney cancer, comes just one week after the FDA accepted the filing for priority review.

Opdivo has now racked up 5 approvals in three distinct tumor types in 12 months. The rapid rate of regulatory successes has been facilitated by some snappy decision making at the FDA, which is getting quicker and quicker at signing off on filings to approve Opdivo in new indications. After the market closed on November 16, BMS said the FDA had accepted an application for the use of Opdivo as a treatment for patients with advanced RCC who have received prior anti-angiogenic therapy. Almost exactly one week later, FDA revealed it had approved Opdivo for use in the indication.

When it accepted the application for priority review, FDA set the action date at March 16, 2016. The quickfire approval continues the trend for FDA to need less and less time to make decisions on Opdivo filings. While the decision date for an Opdivo supplemental biologics license application covering patients with previously untreated advanced melanoma slipped in August, other recent submissions have come in on or well ahead of schedule. The review time for a non-small cell lung cancer filing clocked in at a swift 37 days, while the FDA took just one week to make its latest decision.

BMS built the case for the quick approval on data from CheckMate -025, a trial in which Opdivo outperformed Novartis' ($NVS) Afinitor in terms of median overall survival. Patients in the Opdivo arm of the study had a median overall survival benefit of 25 months, compared with 19.6 months in the group that received Afinitor. BMS stopped the clinical trial early in July when the data monitoring committee found it had already met its primary endpoint. And with such strong data being paired with priority review status, the FDA needed next to no time to make a decision.

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