Bristol Myers Squibb walks on Opdivo's FDA nod for small-cell lung cancer after middling OS data couldn't back approval
In a pitched battle against Merck’s Keytruda, Bristol Myers Squibb’s immunotherapy headliner Opdivo landed a major salvo with a groundbreaking FDA approval for certain lung cancer patients back in 2018. Since that nod, however, Opdivo has turned out clinical duds in that market, and now Bristol is cutting its losses.
Bristol has agreed to give up Opdivo’s third-line-or-later FDA approval for small-cell lung cancer after confirmatory trials for an accelerated nod in that indication back in 2018 failed to show benefit in extending patients’ lives, the drugmaker said Tuesday.
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