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U.S. FDA Grants Approval to Bristol Myers Squibb’s Breyanzi CAR T Cell Therapy for Relapsed or Refractory Follicular Lymphoma

NextEdge Admin

17 May 2024

3 min 32 sec

Bristol Myers Squibb has received accelerated approval from the U.S. Food and Drug Administration (FDA) for Breyanzi® (lisocabtagene maraleucel; liso-cel), a CAR T cell therapy targeting CD19, to treat adult patients with relapsed or refractory follicular lymphoma (FL) who have undergone two or more prior lines of systemic therapy. This approval, based on response rate and duration of response, is contingent upon confirmation of clinical benefit in further trials.

Administered as a one-time infusion, Breyanzi delivers 90 to 110 x 10^6 CAR-positive viable T cells. Its inclusion in the National Comprehensive Cancer Network (NCCN) Guidelines as a Category 2A recommendation for third-line and subsequent therapy underscores its significance in FL treatment.

FL, historically deemed incurable, necessitates effective therapies due to frequent relapses post-frontline treatment. The Phase 2 TRANSCEND FL study demonstrated promising results, with an overall response rate (ORR) of 95.7%, including a complete response (CR) rate of 73.4%. Responses were rapid and durable, with 80.9% of responders maintaining remission at 12 months.

Safety data from clinical trials showed a manageable profile, with cytokine release syndrome (CRS) and neurologic events (NEs) occurring in 53% and 31% of patients, respectively. The safety profile permits outpatient treatment, enhancing accessibility and patient experience.

Dr. M. Lia Palomba, a TRANSCEND investigator, emphasized Breyanzi’s role in addressing the unmet need in FL treatment, offering high response rates and a favorable safety profile. The approval marks a significant advancement, providing hope for lasting remission in patients.

Bristol Myers Squibb offers patient support programs and Cell Therapy 360, a digital service platform facilitating access to information and support. TRANSCEND FL, an open-label Phase 2 study, assessed Breyanzi’s efficacy and safety in relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including FL.

FL, the second most common form of non-Hodgkin lymphoma, typically presents with clusters of white blood cells in lymph nodes or organs. Breyanzi, a CD19-directed CAR T cell therapy, employs a 4-1BB costimulatory domain to enhance CAR T cell expansion and persistence, offering a one-time treatment option for FL patients.

Breyanzi’s approval in multiple regions for various indications underscores its potential as a transformative therapy in the FL treatment landscape.