Bristol Myers announces EMA validation to expand Brevanzi indication

Bristol Myers Squibb announced that the European Medicines Agency, or EMA, has validated its Type II variation application to expand the indication for Breyanzi, or lisocabtagene maraleucel; liso-cel, a CD19-directed chimeric antigen receptor, or CAR, T cell therapy, to include the treatment of adult patients with relapsed or refractory follicular lymphoma, or 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. The application is supported by data from the 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. 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%-30% 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.