FDA approves 1st CAR-T therapy for marginal zone lymphoma

The FDA approved a new indication for Breyanzi on Dec. 4, making it the first CAR T-cell therapy in the U.S. for adults with marginal zone lymphoma who have relapsed or failed treatment after at least two prior lines of therapy.

Three notes:

1. Marginal zone lymphoma is a rare cancer that accounts for 7% of all B-cell non-Hodgkin lymphoma, with about 7,460 new diagnoses each year in the U.S.

2. In a multicenter clinical trial, 95.5% of patients who received the therapy responded to treatment, and 62.1% achieved a complete response, showing no signs of disease on imaging. Responses remained durable after a median follow-up of 21.6 months.3. Breyanzi, developed by Juno Therapeutics, received priority review and orphan drug designation from the FDA.

“Today’s approval represents a major advancement in precision medicine, essentially turning the patient’s immune system into a more effective tool to treat MZL,” said Vinay Prasad, MD, chief medical and scientific officer and director of the FDA’s Center for Biologics Evaluation and Research,, in a Dec. 4 news release. “The FDA continues to optimize its regulatory authority to expand treatment options in the fight against cancer.”