The Cancer Letter

Inside information on cancer research and drug development

Drugs & Targets

FDA grants Priority Review for BMS agent lisocabtagene maraleucel

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Bristol-Myers Squibb Co. said FDA has accepted for Priority Review its Biologics License Application for lisocabtagene maraleucel (liso-cel), the company’s autologous anti-CD19 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. The FDA has set a Prescription Drug User Fee Act goal date of Aug. 17.

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