FDA Decision on Liso-cel, CAR T-cell Therapy for Large B-cell Lymphoma, Due in November

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FDA Decision on Liso-cel, CAR T-cell Therapy for Large B-cell Lymphoma, Due in November
May 12, 2020May 12, 2020
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The U.S. Food and Drug Administration (FDA) has extended by three months its review of Bristol-Myers Squibb’s investigational CAR T-cell therapy, lisocabtagene maraleucel (liso-cel), as a treatment for adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies, the company announced. Liso-cel’s new Prescription Drug User Fee Act (PDUFA) action date is now Nov. 16, 2020, instead of August as first planned. PDUFA dates are deadlines for the FDA to announce an approval decision. The approval request, called a biologics license…

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