FDA Approves First CAR T-Cell Therapy for rrCLL, rrSLL

The FDA has granted accelerated approval for lisocabtagene maraleucel (liso-cel) for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This CD19-directed chimeric antigen receptor (CAR) T-cell product is the first CAR T-cell therapy approved for this purpose. The approval follows successful results from the TRANSCEND CLL 004 study, where 20% of patients achieved a complete response after receiving liso-cel. The therapy has a tolerable safety profile, with low-grade cytokine release syndrome and neurologic events being the most common side effects. This approval represents a significant breakthrough in the treatment of incurable CLL and SLL.

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