FDA grants accelerated approval to Bristol Myers Squibb’s Breyanzi for follicular lymphoma

Bristol Myers Squibb (NYSE: BMY) has announced a significant breakthrough in the treatment of follicular lymphoma with the U.S. Food and Drug Administration (FDA) granting accelerated approval to Breyanzi (lisocabtagene maraleucel; liso-cel). This approval marks a pivotal moment for patients with relapsed or refractory follicular lymphoma who have undergone at least two prior systemic therapies. Breyanzi, a CD19-directed chimeric antigen receptor (CAR) T cell therapy, is now a recognized treatment option, included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for B-cell Lymphomas as a Category 2A recommendation.

Groundbreaking Clinical Results

The approval is based on impressive response rates and the duration of those responses as demonstrated in the Phase 2 TRANSCEND FL study, which is the largest clinical trial to evaluate a CAR T cell therapy in this patient population. Within this study, Breyanzi achieved an overall response rate (ORR) of 95.7%, with a complete response (CR) rate of 73.4%. These results highlight the therapy’s efficacy in inducing rapid and durable responses, with a significant proportion of patients still in remission at 12 and 18 months post-treatment.

Bristol Myers Squibb’s Breyanzi, a CAR T cell therapy, received FDA accelerated approval for treating relapsed or refractory follicular lymphoma, offering hope for lasting remission.

Safety Profile and Administration

Breyanzi is administered as a one-time infusion, offering a potential for lasting remission in a convenient treatment form. The therapy has a well-established safety profile, with manageable side effects such as cytokine release syndrome (CRS) and neurologic events, which are critical considerations for patient management. The outpatient treatment capability of Breyanzi allows for a broader range of treatment settings, enhancing patient access to this innovative therapy.

Expert and Community Reactions

The medical community, including specialists from top institutions like Memorial Sloan Kettering Cancer Center, has praised the FDA’s decision. Dr. M. Lia Palomba, a TRANSCEND investigator, emphasized the significant unmet need for effective treatments in relapsed or refractory follicular lymphoma, noting the remarkable efficacy of Breyanzi in clinical trials.

Furthermore, Meghan Gutierrez, CEO of the Lymphoma Research Foundation, highlighted the importance of this approval for the lymphoma community, offering new hope and a meaningful treatment option for patients.

Ongoing Support and Access Programs

Bristol Myers Squibb is committed to supporting patients and healthcare providers with comprehensive programs and resources. This includes the innovative digital service platform, Cell Therapy 360, which provides essential information, updates, and support to optimize the treatment experience and ensure broad access to Breyanzi.