CHMP green-lights label expansion for BMS’ Breyanzi in the EU

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Bristol Myers Squibb’s Breyanzi, a CD19-directed CAR-T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received two or more prior lines of systemic therapy, teeing up the approval decision for the European Commission.

The committee adopted a positive opinion based on data 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 FL, which enrolled adults with relapsed or refractory FL treated with Breyanzi after two or more prior lines of systemic therapy. In the study, Breyanzi demonstrated a high overall response rate of 97.1% and complete response rate of 94.2%. The safety of Breyanzi in FL was consistent with the well-established safety profile of the therapy observed across clinical trials, with no new safety signals observed.

CHMP opinion in hand, the EC will deliver its final decision within approximately two months.

Breyanzi is currently approved in the EU for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and FL grade 3B, who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy, and for the treatment of adult patients with relapsed or refractory DLBCL, PMBCL and FL3B after two or more lines of systemic therapy.

In May 2024, The U.S. FDA approved the label expansion for Breyanzi for use in relapsed or refractory follicular lymphoma following two lines of therapy, as well as relapsed or refractory mantle cell lymphoma after two prior lines of therapy.