FDA approves Breyanzi for relapsed, refractory marginal zone lymphoma

The U.S. Food and Drug Administration has approved a new indication for Breyanzi (lisocabtagene maraleucel) for treating adults with marginal zone lymphoma (MZL) who have failed treatment or relapsed after two or more prior lines of therapy.

Breyanzi is a chimeric antigen receptor T-cell therapy that genetically engineers a patient’s own T-cells (collected via leukapheresis) to target and kill cancer cells. Patients receive a single dose of Breyanzi two to seven days after completing preparatory chemotherapy to deplete the recipient’s lymphocytes. For this application, the FDA granted Breyanzi priority review and orphan drug designation.

The approval was based on an open-label, multicenter, single-arm trial that included 66 patients, of whom 95.5% experienced a response to treatment and 62.1% had a complete response without signs of marginal zone lymphoma on imaging scans. After a median follow-up of 21.6 months, the responses were durable. The most common adverse reactions included cytokine release syndrome, diarrhea, fatigue, musculoskeletal pain, and headache.

“Today’s approval reflects the FDA’s continuing commitment to advance cell therapies to meet the needs of patients with rare cancers,” Vijay Kumar, M.D., from the FDA Center for Biologics Evaluation and Research, said in a statement. “In granting approval, FDA took into consideration the high and durable response rate following a one-time treatment in patients with MZL, almost half of whom had either progression within two years of diagnosis or had refractory disease.”

Approval of Breyanzi was granted to Juno Therapeutics.

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