BMS expands Breyanzi label in Europe with follicular lymphoma approval

The European Commission has granted approval to Bristol Myers Squibb’s CD19-directed CAR-T cell therapy, Breyanzi, for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) had green-lighted the label expansion into relapsed or refractory follicular lymphoma back in January, teeing up the approval decision for the European Commission.

The decision is based on results from the global, phase 2 TRANSCEND FL study, the largest clinical trial to date to evaluate a CAR-T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma, including follicular lymphoma. Among patients treated in the third-line plus setting, Breyanzi demonstrated a high overall response rate of 97.1% and complete response rate of 94.2%, the study’s primary and key secondary endpoints, respectively. Responses were rapid, durable and demonstrated sustained efficacy, with a median time to first response of 0.95 months and 75.7% of patients still in response at 18 months.

The expanded approval is applicable to all EU member states as well as the European Economic Area countries Iceland, Norway and Liechtenstein.

Breyanzi is already approved in the EU for patients with relapsed or refractory diffuse large B-cell lymphoma, high grade B-cell lymphoma, and primary mediastinal large B-cell lymphoma who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy, and for the treatment of adult patients who relapsed or are refractory after two or more lines of systemic therapy.

First approved in the U.S. in 2021, Breyanzi is now FDA approved for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy; relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior lines of therapy; relapsed or refractory follicular lymphoma in adult patients who have received two or more prior lines of systemic therapy; and relapsed or refractory mantle cell lymphoma in patients who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.