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The FDA has approved lisocabtagene maraleucel (Breyanzi, Bristol-Myers Squibb) for relapsed or refractory marginal zone lymphoma (MZL) in adults after at least two prior lines of systemic therapy.
Lisocabtagene maraleucel (liso-cel) is now the only CD19-directed chimeric antigen receptor (CAR) T-cell therapy approved for MZL. The approval marks liso-cel’s fifth indication, the most of any CD19-directed CAR T-cell therapy, BMS said in a press release.
Prior approvals are also in the relapsed or refractory setting and include large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia/small lymphocytic lymphoma.
MZL is a slow-growing subtype of non-Hodgkin lymphoma (NHL), accounting for about 7% of all NHL cases and typically diagnosed in older adults. Prognosis is generally favorable, but in patients who relapse or become refractory, NHL can transform into diffuse large B-cell lymphoma.
Basis for Approval
Liso-cel’s new approval was based on the MZL cohort of the single arm TRANSFORM FL trial, which included 66 patients in the third or later lines; 95.5% responded to the one-time treatment, with 62.1% having a complete response. Responses were durable in 90.1% of patients at 2 years, according to the BMS press release.
In terms of safety, 76% of MZL patients developed cytokine release syndrome, which was grade 3 or worse in 4.5%. Nervous system disorders included headache (21%, grade ≥ 3 in 1.5%), encephalopathy (21%, grade ≥ 3 in 1.5%), tremor (21%), dizziness (16%), and aphasia (10%).
Labeling also warns of hypersensitivity reactions, serious infections, prolonged cytopenias, hypogammaglobulinemia, and secondary malignancies.
Cost of Treatment
One-time treatment costs $567,237.18, according to drugs.com. BMS noted liso-cel is broadly covered by commercial and government insurance programs.
M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com
