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FDA Approves Bristol-Myers/2seventy Bio's Abecma For Earlier Use In Pretreated Blood Cancer Patients With Updated Boxed Warning On Secondary Cancer
Friday, the FDA approved Bristol-Myers Squibb Company (NYSE:BMY) and 2seventy Bio Inc’s (NASDAQ:TSVT) Abecma (idecabtagene vicleucel; ide-cel) for adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy.
The approval is based on results from the KarMMa-3 trial that showed Abecma helped extend the time before disease progression by 13.3 months on average in patients whose cancer has returned or stopped responding to at least two prior treatments compared to 4.4 months progression-free survival seen in trial patients who received standard of care.
This approval expands Abecma’s indication, making it ...