BMS expands FDA approval for Breyanzi into marginal zone lymphoma

The FDA has approved Bristol Myers Squibb’s Breyanzi for use in for adults with relapsed or refractory marginal zone lymphoma (MZL), making it the only CAR-T cell therapy approved by the agency for five cancer types.

First approved in the U.S. in 2021, 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.

The FDA had accepted the supplemental BLA for Breyanzi back in August as treatment for relapsed or refractory MZL, granting it priority review and assigning a PDUFA date of December 5, 2025. The recent approval is based on results from the MZL cohort in TRANSCEND FL, an open-label, multicenter, multi-cohort, single-arm study in which Breyanzi demonstrated high rates of durable responses and a consistent safety profile.

In addition to MZL, 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.

BMS recently announced that the European Commission haf granted approval to Breyanzi for the treatment of adult patients with relapsed or refractory MCL after at least two lines of systemic therapy including a Bruton’s tyrosine kinase inhibitor, marking the fourth approval for the therapy in Europe.