European Medicines Agency validates application for CAR-T cell therapy Breyanzi, for relapsed or refractory follicular lymphoma – BMS

Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its Type II variation application to expand the indication for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. Validation of the application confirms the submission is complete and allows the scientific review to begin under the EMA’s centralized review procedure.

“Follicular lymphoma impacts a significant number of people, and those with relapsed or refractory disease tend to experience shorter responses with each new line of therapy,” said Anne Kerber, senior vice president, head of Late Clinical Development, Hematology, Oncology and Cell Therapy (HOCT), Bristol Myers Squibb. “ Breyanzi represents a differentiated CAR T cell therapy, and we look forward to working with the European Medicines Agency to bring this important treatment option to patients with relapsed or refractory follicular lymphoma with the goal of improving outcomes and providing lasting remission.”

The application is supported by data from the Phase II 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 (NHL), including FL. The study enrolled adults with relapsed or refractory FL treated with Breyanzi in the high-risk second-line and third-line plus setting. In the study, Breyanzi demonstrated a high overall response rate, the study’s primary endpoint, with responses being deep and durable. The safety of Breyanzi in FL is consistent with the well-established and manageable safety profile of Breyanzi observed across clinical trials.

Follicular lymphoma is the second most common form of NHL, accounting for 20 to 30 percent of all NHL cases. FL has historically been considered an incurable disease with patients frequently relapsing following front-line therapy and prognosis worsening after each subsequent relapse. Despite advances in treatment, there remains an unmet need for additional options that offer treatment-free intervals with durable, complete responses.