The U.S. FDA has accepted the supplemental BLA for Bristol Myers Squibb’s Breyanzi as a potential treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy.
The FDA has granted the application priority review and assigned a PDUFA date of December 5, 2025.
The application is based on results from the primary analysis of the MZL cohort in TRANSCEND FL, an open-label, multicenter, phase 2, single-arm study, which was shared in an oral presentation during the 2025 International Conference on Malignant Lymphoma in June 2025. MZL is the third most common lymphoma, accounting for about 7% of all non-Hodgkin lymphoma cases.
“While initial therapy for MZL can be effective, multiple relapses over the course of several years are common, leaving patients in need of a new treatment option that can provide high, lasting response rates,” said Rosanna Ricafort, vice president, senior global program lead for hematology and cell therapy, BMS.
Breyanzi is a CD19-directed CAR-T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. It is approved in the U.S. for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy, has received accelerated approval for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of therapy and relapsed or refractory follicular lymphoma (FL) in the third-line plus setting, and is approved for the treatment of relapsed or refractory mantle cell lymphoma (MCL) in the third-line plus setting.
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