FDA Approves Bristol Myers' Breyanzi for Relapsed/Refractory Follicular Lymphoma

Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for adult patients with relapsed or refractory follicular lymphoma (FL) who have undergone at least two prior lines of systemic therapy. This approval is based on response rate and duration of response, with ongoing approval dependent on further verification of clinical benefits in confirmatory trials.

Breyanzi is now included in the National Comprehensive Cancer Network (NCCN®) Clinical Practice Guidelines in Oncology for B-cell Lymphomas as a third-line and subsequent therapy for relapsed or refractory FL. It is administered as a one-time infusion containing 90 to 110 million CAR-positive viable T cells.

Bryan Campbell, Senior Vice President and Head of Commercial, Cell Therapy at Bristol Myers Squibb, noted that Breyanzi is pivotal in their cell therapy portfolio. He highlighted its potential for lasting remission with a single infusion and a safety profile that facilitates both inpatient and outpatient administration in certified treatment centers across the U.S.

Follicular lymphoma is generally considered incurable, with patients often experiencing relapse after frontline therapy, leading to a worsening prognosis. There remains a significant need for treatments that offer durable, complete responses and treatment-free intervals.

The Phase 2 TRANSCEND FL study, which is the largest of its kind evaluating a CAR T cell therapy for relapsed or refractory FL, forms the basis for the FDA’s approval. In the primary efficacy analysis set (n=94) treated with Breyanzi, the overall response rate (ORR) was 95.7%, with a complete response (CR) rate of 73.4%. Responses were rapid and durable, with a median time to response of one month and a median duration of response not reached, indicating sustained benefit. At 12 months, 80.9% of responders remained in response, and 77.1% continued to respond at 18 months.

Dr. M. Lia Palomba, an investigator in the TRANSCEND trial, emphasized that patients with relapsed or refractory FL typically see diminishing response durations with subsequent treatments. She described the FDA’s approval of liso-cel as a significant advance, providing a new option with high response rates and an established safety profile.

Breyanzi has demonstrated a consistent safety profile in clinical trials. Any grade of cytokine release syndrome (CRS) occurred in 53% of patients, with Grade 3 or higher CRS in 4% of patients. Neurologic events occurred in 31% of patients, with Grade 3 or higher events in 10%. These adverse events were manageable, allowing for outpatient treatment options.

Meghan Gutierrez, CEO of the Lymphoma Research Foundation, underscored the urgent need for new treatments for relapsed or refractory FL, celebrating the approval of Breyanzi as a significant milestone providing hope for lasting remission.

Bristol Myers Squibb supports patients and caregivers through various programs, enhancing access to therapies including Breyanzi. They also offer Cell Therapy 360, a digital platform providing treatment information, manufacturing updates, and support resources.

TRANSCEND FL is a global, multicenter, Phase 2 trial assessing Breyanzi's efficacy and safety in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including FL. The primary measure is overall response rate, while secondary measures include complete response rate, duration of response, progression-free survival, and safety.

Follicular lymphoma is the second most common type of non-Hodgkin lymphoma, accounting for 20 to 30 percent of cases. It is characterized by periods of remission and relapse, becoming harder to treat over time.

Breyanzi, a CD19-directed CAR T cell therapy, is approved in the U.S. for various types of relapsed or refractory lymphoma and has received accelerated approval for chronic lymphocytic leukemia or small lymphocytic lymphoma after two prior lines of therapy. It is also approved in Japan, the European Union, and Switzerland for certain lymphoma treatments.

Bristol Myers Squibb continues to develop Breyanzi for other lymphoma types, with ongoing clinical studies available for more information on clinicaltrials.gov.