Bristol Myers’ Breyanzi receives positive CHMP opinion in follicular lymphoma

Bristol Myers (BMY) announced the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has recommended approval of Breyanzi, a CD19-directed chimeric antigen receptor – 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. The European Commission, or EC, which has the authority to approve medicines for the European Union, EU, will now review the CHMP recommendation. The CHMP 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, or NHL, including FL. In the study, 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 and durable, and demonstrated sustained efficacy with 75.7% of patients in response at 18 months. The safety of Breyanzi in FL is consistent with the well-established safety profile of Breyanzi observed across clinical trials. In the EU, the EC delivers its final decision within approximately two months following receipt of the CHMP opinion. Once issued, the decision will be applicable to all EU member states as well as in the European Economic Area countries Iceland, Norway and Liechtenstein.