FDA approves lisocabtagene maraleucel for R/R large B-cell lymphoma

On February 5, 2021, it was announced that the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after ≥ 2 lines of therapy. This includes patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma Grade 3B.¹

This approval was based on the results of the phase I TRANSCEND-NHL-001 study (NCT02631044), previously reported on the Lymphoma Hub and published in The Lancet. Liso-cel demonstrated a 73% overall response rate, with a median duration of response not yet reached for those who achieved a complete response (54%). With regards to safety, 4% of patients experienced Grade ≥ 3 cytokine release syndrome and 12% experienced Grade ≥ 3 neurologic toxicities.¹