FDA approves Breyanzi CAR-T for follicular lymphoma

The FDA granted accelerated approval to lisocabtagene maraleucel (Breyanzi) for the treatment of adults with relapsed or refractory follicular lymphoma who have received at least two prior lines of systemic therapy. The drug, also known as liso-cel, is a CD19-directed chimeric antigen receptor T-cell therapy. The approval was based on results from the phase 2 TRANSCEND-FL trial, which demonstrated an overall response rate of 95.7% among participants. Common adverse reactions included cytokine release syndrome, headache, musculoskeletal pain, fatigue, constipation, and fever. Lisocabtagene maraleucel comes with a Risk Evaluation and Mitigation Strategy due to the risk for fatal or life-threatening CRS and neurologic toxicities.

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