Beat-up Bristol gets a boost as FDA approves Opdivo in bladder cancer


After a string of setbacks, Bristol-Myers Squibb was badly in need of some good news on the immuno-oncology front, and Thursday, that’s what it got.

The FDA has green-lighted Opdivo as a treatment for urothelial carcinoma, the most common type of bladder cancer. The checkpoint inhibitor is now good to go in patients whose disease progresses during or after treatment with platinum chemo, or whose disease progresses within a year of receiving neoadjuvant or adjuvant therapy with platinum chemo.

It’s good news for Bristol, which has had a rough few months. Last August, Opdivo flopped a first-line monotherapy study in non-small cell lung cancer, and nemesis Keytruda from Merck rubbed salt in the wound by winning an FDA go-ahead in the same indication not long after. Then, last month, Merck surprised industry watchers with a first-line chemo combo filing for Keytruda, while Bristol found itself unable to file early on its own combo, a pairing of Opdivo and Yervoy.


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The setbacks sunk shares enough to get some analysts wondering whether BMS could soon make a takeover target—perhaps for Pfizer, whose own immuno-oncology program is well behind many of its Big Pharma rivals’.

Related: The top 15 best-selling cancer drugs in 2022

While the bladder cancer nod will give Opdivo a needed boost, Bristol will still have some serious I-O competition to contend with in the space. Roche’s Tecentriq got a head start on the rest of field last May, when it became the first checkpoint med to grab a bladder-cancer OK. AstraZeneca is expecting an FDA decision in Q2 on durvalumab, and Merck Friday announced that U.S. regulators had granted Keytruda a breakthrough designation in the second-line setting.

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