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In a landmark OK, FDA green-lights Bristol-Myers’ Opdivo for a niche group of metastatic lung cancer patients

Bristol-Myers Squibb $BMY may have lost the long-running battle with Merck $MRK for leading the industry on overall checkpoint revenue, but they are still fighting for every edge they can get looking for a comeback to the top spot.

Today the biopharma company announced that the FDA has approved its blockbuster PD-1 drug Opdivo for metastatic small cell lung cancer patients who had failed chemo and one other therapy. The OK is based on SCLC cohort data that Bristol-Myers assembled in its CheckMate-032 Phase I/II trial — with a 12% response rate that included 1 complete and 12 partial responses. 

A high rate of adverse events led physicians to hold back one of the doses of Opdivo in 25% of the patients, while 10% discontinued therapy.

That’s not a great performance, but it’s better than what had been available for patients and marks the first approval for this (very tough) category of lung cancer patients in close to 20 years.

Leora Horn

As researchers have noted, this is a tough disease to fight, with a 2% 5-year survival rate expected for the 27,000 patients diagnosed in the US this year. It also highlights the showdown between Bristol-Myers Squibb and Merck, which has been making steady progress on the lung cancer field for frontline use with Keytruda. Another three manufacturers are crowding in behind them, with Regeneron and Sanofi expected to join the group soon with an OK for cemiplimab.

The FDA, meanwhile, is continuing to illustrate its eager acceptance of early-stage data as it continues to hustle along accelerated approvals in cancer. And you can look for rival I/O therapies to challenge Bristol-Myers here.

“While immuno-oncology innovations have dramatically changed how oncologists approach certain cancers, we have had limited progress for patients with small cell lung cancer,” said Leora Horn, associate professor of medicine at Vanderbilt University Medical Center. “Today’s approval of nivolumab is particularly exciting considering it is the first checkpoint inhibitor approved for these specific patients, and now we can finally treat this devastating disease from a different angle.”


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