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FDA Grants Accelerated Approval to Breyanzi for Relapsed or Refractory Follicular Lymphoma


This is the second accelerated approval the FDA has granted to Bristol Myers Squibb’s chimeric antigen receptor T-cell therapy in the past few months.

Image credit: AbudanceGuy | stock.adobe.com

Image credit: AbudanceGuy | stock.adobe.com

The FDA has granted accelerated approval to Bristol Myers Squibb’s chimeric antigen receptor (CAR) T-cell therapy Breyanzi (lisocabtagene maraleucel) to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL) who previously received two or more lines of systemic therapy.1 This is the second accelerated approval the FDA has granted to Breyanzi in the past few months, following a regulatory decision in March to give the green light to the drug for adults with R/R chronic lymphocytic leukemia or small lymphocytic lymphoma who were previously administered at least two lines of therapy, including a Bruton’s tyrosine kinase inhibitor and a BCL-2 inhibitor.2

“Breyanzi is a cornerstone of our cell therapy portfolio, providing a differentiated profile across a wide array of B-cell malignancies,” said Bryan Campbell, senior vice president, head of Commercial, Cell Therapy, Bristol Myers Squibb. “Today’s approval of Breyanzi for relapsed or refractory FL provides an option with potential for lasting remission in a one-time infusion and a safety profile that allows for administration and monitoring in both the inpatient and outpatient setting in an increasing number of certified treatment centers in the US.”1

The most recent approval was based on findings from the Phase II, open-label, multicenter, single-arm TRANSCEND-FL trial (NCT04245839). According to Bristol Myers Squibb, this was the largest clinical trial to date that analyzed a CAR T-cell therapy in patients with R/R indolent B cell non-Hodgkin lymphoma, including high-risk second-line FL.

Investigators enrolled patients with R/R FL who were previously administered two or more lines of systemic therapy that included an anti-CD20 antibody and an alkylating agent. Patients were required to have adequate bone marrow function to receive lymphodepleting chemotherapy, as well as an ECOG performance status of 0 or 1.

Exclusion criteria included evidence or a history of composite diffuse large B-cell lymphoma and FL or transformed FL; a WHO subclassification of duodenal-type FL; central nervous system–only involvement by malignancy; or having been previously administered CAR T-cell therapy or other genetically-modified cell therapy.3

Treatment with Breyanzi (n = 94) was found to produce an overall response rate (ORR) of 95.7% (95% CI, 89.5%-98.8%). Median duration of response (DOR) was not yet reached (NR; 95% CI, 18.04-NR) at a median follow-up of 16.8 months (95% CI, 16.3-17.0), with 80.9% of responders remaining in response at 12 months and 77.1% of responders remaining in response at 18 months.1

Patients administered Breyanzi achieved a complete response rate of 73.4% (95% CI: 63.3-82.0), which required a negative bone marrow biopsy for confirmation. Investigators stated that responses were rapid and durable, showing a median time to response of one month (range: 0.6-3.3).1

“In the treatment of relapsed or refractory follicular lymphoma, patients often cycle through treatments with typically shorter responses with each new line of therapy. Those who have experienced early disease progression have notably poor prognosis,” TRANSCEND investigator M. Lia Palomba, MD, lymphoma and cell therapy specialist, Memorial Sloan Kettering Cancer Center, said in a press release. “The FDA approval of [Breyanzi] for patients with relapsed or refractory FL is an important advancement in addressing an ongoing unmet need in the FL treatment paradigm, providing patients a new option that has shown remarkably high response rates and an established safety profile.”1


1. Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi Approved by the U.S. Food and Drug Administration for Relapsed or Refractory Follicular Lymphoma. News release. Bristol Myers Squibb. May 15, 2024. May 16, 2024. https://news.bms.com/news/details/2024/Bristol-Myers-Squibbs-CAR-T-Cell-Therapy-Breyanzi-Approved-by-the-U.S.-Food-and-Drug-Administration-for-Relapsed-or-Refractory-Follicular-Lymphoma/default.aspx

2. US FDA approves Bristol Myers Squibb’s Breyanzi ® as the first and only CAR T cell therapy for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). News release. Bristol Myers Squibb. March 14, 2024. Accessed May 16, 2024. https://news.bms.com/news/details/2024/U.S.-FDA-Approves-Bristol-Myers-Squibbs-Breyanzi--as-the-First-and-Only-CAR-T-Cell-Therapy-for-Adults-with-Relapsed-or-Refractory-Chronic-Lymphocytic-Leukemia-CLL-or-Small-Lymphocytic-Lymphoma-SLL/default.aspx

3. A study to evaluate the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL) (TRANSCEND FL). ClinicalTrials.gov. Updated November 30, 2023. Accessed May 15, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT04245839

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