BMS expands EU approval for Breyanzi into mantle cell lymphoma

Bristol Myers Squibb announced that the European Commission has granted approval to Breyanzi for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase inhibitor, marking the fourth approval for the CD19-directed CAR-T cell therapy in Europe.

The expanded approval is based on results from the MCL cohort of TRANSCEND NHL 001, which enrolled adult patients with relapsed or refractory MCL who had received at least two prior lines of therapy including a BTK inhibitor. Among patients treated in the third-line plus setting, Breyanzi demonstrated a high overall response rate of 82.7% and complete response rate of 71.6% — meeting the study’s primary and key secondary endpoints, respectively.

Breyanzi, which was first approved in the U.S. in 2021, 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. BMS has continued to expand the use of the therapy, winning approval in the EU in March 2025 for relapsed or refractory follicular lymphoma. In August, the FDA granted priority review to BMS’ supplemental BLA in relapsed or refractory marginal zone lymphoma — a potential fifth cancer type for the drug in the U.S. — assigning a PDUFA date of December 5, 2025.