FDA Approves Breyanzi for Follicular Lymphoma

The FDA has granted accelerated approval for Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel; liso-cel) to treat adult patients with relapsed or refractory follicular lymphoma have received two or more prior lines of systemic therapy.

Follicular lymphoma is the second most common, slow-growing form of non-Hodgkin lymphoma (NHL), accounting for 20% to 30% of all NHL cases. Most patients are over the age of 50. It develops when white blood cells cluster together to form lumps in a person’s lymph nodes or organs.

Breyanzi is a CD19-directed chimeric antigen receptor (CAR) T cell therapy that is already approved to treat adult patients with large B-cell lymphoma and with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Related: FDA Approves Breyanzi for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Breyanzi is derived from a patient’s own T cells that have been engineered to target CD19 B cells. Breyanzi includes a box warning about the risk of cytokine release syndrome, a large release of cytokines into the blood, which triggers overreaction of the immune system and neurological toxicities. The list price for Breyanzi is $487,477.43, according to Drugs.com. For full year 2023, Breyanzi generated revenue of $364 million.

Breyanzi is also now included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for B-cell Lymphomas as a Category 2A recommendation for third-line and subsequent therapy for relapsed or refractory FL.

In relapsed or refractory FL, the application is based on results from the TRANSCEND FL study. In the study, Breyanzi achieved an overall response rate of 95.7% among the 94 patients evaluated for efficacy. The complete response (CR) rate was 73.4%, and the median time to response was one month. About 80.9% of responders continued to have a response at 12 months, and 77.1% of responders remained in response at 18 months.

Results from the primary analysis of TRANSCEND FL were presented at the 2023 International Conference on Malignant Lymphoma.

M. Lia Palomba, M.D.

“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,” M. Lia Palomba, M.D., TRANSCEND investigator and lymphoma and cell therapy specialist, Memorial Sloan Kettering Cancer Center, said in a news release.

Breyanzi is also being reviewed by the FDA to treat patients with relapsed or refractory mantle cell lymphoma (MCL). The Prescription Drug User Fee Act (PDUFA) goal date for this indication is May 31, 2024.