Bristol Myers Squibb was granted accelerated approval from the FDA for Breyanzi  (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent on verification and description of clinical benefit in confirmatory trial(s). 
 
In relapsed or refractory FL, Breyanzi is delivered as a one-time infusion with a single dose containing 90 to 110 x 10⁶ CAR-positive viable T cells. The approval includes Boxed WARNINGS for Breyanzi regarding Cytokine Release Syndrome (CRS), Neurologic Toxicities, and Secondary Hematological Malignancies.
 
Historically, FL has been considered an incurable disease, and patients frequently relapse following front-line therapy, with prognosis worsening after each subsequent relapse. Despite advances in treatment, there remains an unmet need for additional options that offer treatment-free intervals with durable, complete responses.
 
The Phase 2 TRANSCEND FL study included the largest primary analysis set of patients with relapsed or refractory FL of a clinical trial evaluating a CAR T cell therapy in this patient population. In patients treated with Breyanzi in the third-line plus setting, the overall response rate (ORR) was 95.7%, as defined as the percentage of patients achieving a partial or complete response per an Independent Review Committee. The complete response (CR) rate was 73.4% and required a negative bone marrow biopsy for confirmation. Responses were rapid and durable with a median time to response of one month and median duration of response (DOR) not reached, with 80.9% of responders remaining in response at 12 months, and 77.1% of responders remaining in response at 18 months. 
 
Breyanzi has exhibited a consistent safety profile and across clinical trials, any grade cytokine release syndrome (CRS) occurred in 53% of patients, including Grade >3 CRS in 4% of patients. The median time to onset was 5 days. Any grade neurologic events (NEs) occurred in 31% of patients, with Grade >3 NEs occurring in 10% of patients. The median time to onset of NEs was 8 days. The safety profile of Breyanzi allows for the option of outpatient treatment and management of patients.