FDA set a target action date of August 17 for B-MS' lisocabtagene maraleucel
US pharma major Bristol-Myers Squibb (NYSE: BMY) today announced that the US Food and Drug Administration has accepted for Priority Review its Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel).
Liso-cel is the company’s autologous anti-CD19 chimeric antigen receptor (CAR) T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies. It came into B-MS’s portfolio with the $74 billion acquisition of Celgene and was seen as one of the latter’s most important assets.
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 17, 2020.
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