The U.S. Food and Drug Administration (FDA) has approved Breyanzi (Lisocabtagene maraleucel) as the first CAR T-cell therapy for marginal zone lymphoma (MZL) in adults who have not responded to or relapsed after two or more previous treatments.
Breyanzi is a type of therapy where a patient’s own immune cells (T-cells) are genetically modified to target and kill cancer cells.
Marginal zone lymphoma is a rare, slow-growing cancer of the lymphatic system, making up about 7% of all B-cell non-Hodgkin lymphoma cases, with around 7,460 new cases each year in the U.S. Patients with MZL who don’t respond to or relapse after treatment tend to have lower survival rates.
The safety and effectiveness of Breyanzi were tested in a clinical trial with adults who had relapsed or not responded to at least two previous treatments. Patients' immune cells were collected and used to create Breyanzi, which was then given to them after chemotherapy. Out of 77 patients treated, 95.5% had a positive response to the therapy, and 62.1% showed no signs of the disease on imaging scans. These positive results lasted for a median follow-up of about 22 months.
Executive Statement
According to Vinay Prasad, M.D., M.P.H., Chief Medical and Scientific Officer and Director of the FDA’s Center for Biologics Evaluation and Research, this approval represents a major advancement in precision medicine, essentially turning the patient’s immune system into a more effective tool to treat MZL. The FDA continues to optimize its regulatory authority to expand treatment options in the fight against cancer.
According to Vijay Kumar M.D., Acting Director, Office of Therapeutic Products in the FDA’s Center for Biologics Evaluation and Research, this approval reflects the FDA’s continuing commitment to advance cell therapies to meet the needs of patients with rare cancers. 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.