MedCity News December 30, 2024
Opdivo Qvantig, administered by injection in less than five minutes, is now FDA approved for solid tumor indications covered by Opdivo, a 30-minute intravenous infusion. The new product will help Bristol Myers Squibb compete with biosimilars as Opdivo faces looming patent expiration.
Bristol Myers Squibb has won FDA approval for an injectable version of its blockbuster cancer immunotherapy Opdivo, a regulatory decision that gives patients a more convenient dosing option and provides the pharmaceutical giant a new way to fend off coming competition.
The pivotal test for injectable Opdivo evaluated the drug in renal cell carcinoma, but the approval announced late Friday spans all of the approved solid tumor indications covered by approvals for intravenously infused Opdivo as a monotherapy....
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