BMS scores 5th indication for Breyanzi with FDA marginal zone lymphoma nod
With FDA approval to treat marginal zone lymphoma (MZL), Bristol Myers Squibb’s Breyanzi has become the first CAR-T therapy in the indication, as well as the first CAR-T to reach the market for five different types of blood cancer.
The U.S. regulator has endorsed the one-time infused CD19-directed treatment for adult patients with relapsed or refractory MZL who have received at least two lines of prior therapy.
Breyanzi, which broke through in 2021 with a nod for large B-cell lymphoma, has also been blessed by the U.S. regulator to treat mantle cell lymphoma (MCL) and follicular lymphoma (FL), as well as chronic lymphocytic lymphoma (CLL) and small lymphocytic lymphoma (SLL).
The latest endorsement gives BMS a leg-up on Gilead’s CD19-directed duo of Yescarta and Tecartus, which have been approved for a combined four blood cancer indications, with the latter CAR-T owning a unique nod in B-cell acute lymphoblastic leukemia.
As for MZL, which accounts for roughly 7% of all non-Hodgkin’s lymphoma cases, the slow-growing disorder develops when white blood cells clump together in the lymph nodes or organs. Remission is often accomplished with initial therapy, but relapse is common and can occur often and over the span of several years. Some MZL cases can progress into large B-cell lymphoma, which is more aggressive.
“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,” Vinay Prasad, M.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER), said in a release.
Setting Breyanzi up for approval included results from the phase 2 Transcend FL trial, which enrolled 66 MZL patients and reported a 95% overall response rate, with 62% of participants achieving a complete response. Of the responders, 90% maintained their response through 24 months.
With MZL, there is a “pressing need for new treatment options with durable outcomes,” according to study investigator M. Lia Palomba, M.D., a lymphoma and cell therapy specialist at the Memorial Sloan Kettering Cancer Center.
Palomba characterized the approval as “a significant advancement in redefining the treatment landscape and providing patients with an option that has demonstrated high rates of responses with an established safety profile.”
