“As a company at the forefront of advancing therapies that transform outcomes for some of the most difficult-to-treat cancers, CAR T cell therapies are a significant focus of our research, and Breyanzi remains a cornerstone of our cell therapy portfolio and pipeline,” said Anne Kerber, Senior Vice President, Head of Late Clinical Development, Hematology, Oncology and Cell Therapy (HOCT), Bristol Myers Squibb. “This is another important step in our commitment to delivering Breyanzi to more patients across indications, as well as expanding into new regions, especially for diseases with continued unmet need such as relapsed or refractory FL, which is considered incurable.”

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 (NHL), 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% (95% CI: 91.7–99.4) and complete response rate of 94.2% (95% CI: 87.8–97.8), the study’s primary and key secondary endpoints, respectively. Responses were rapid and durable, and demonstrated sustained efficacy with 75.7% (95% CI: 66.0–83.0) 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, with no new safety signals observed.

FL is an incurable, slow-growing form of NHL, characterized by cycles of remission and relapse. While significant advancements have been made in FL treatment in the last two decades, relapsed or refractory FL continues to represent an area of high unmet need, particularly among the nearly 20% of patients that experience disease relapse or progression within two years of first-line treatment. Newer treatments, such as CAR T cell therapies, have shown high rates of complete, durable responses and a manageable safety profile in clinical trials, potentially paving the way for lasting results in the routine care setting.

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 (EEA) countries Iceland, Norway and Liechtenstein.*

Breyanzi is currently approved in the EU for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and FL grade 3B (FL3B), 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.

Bristol Myers Squibb thanks the patients and investigators involved in the TRANSCEND FL study.

*Centralized Marketing Authorization does not include approval in the United Kingdom (UK).