FDA Approves Breyanzi for Mantle Cell Lymphoma

The FDA has approved Breyanzi (lisocabtagene maraleucel; liso-cel) to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.

Mantle cell lymphoma is an aggressive, rare form of non-Hodgkin lymphoma (NHL), representing roughly 3% of all NHL cases. Mantle cell lymphoma occurs more frequently in older adults with an average age at diagnosis in the mid-60s. In mantle cell lymphoma, relapse after initial treatment is common.

Michael Wang, M.D.

“There have been few advances in the treatment of relapsed or refractory MCL, and prognosis worsens for patients after each subsequent relapse, often leaving them with high disease burden and difficulty achieving deep and durable responses,” said Michael Wang, M.D., lead investigator and Puddin Clarke Endowed Professor, Department of Lymphoma and Myeloma, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center in Houston, said in a news release.

Developed by Bristol Myers Squibb, 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; relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma; and relapsed or refractory follicular 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.

Bristol Myers Squibb offers Cell Therapy 360, which includes access and reimbursement support, including copay assistance to cover out-of-pocket costs for commercially insured patients.

Related: FDA Approves Breyanzi for Follicular Lymphoma

In mantle cell lymphoma, Breyanzi is delivered as a one-time infusion with a single dose.

The approval for mantle cell lymphoma is based on results from the MCL cohort of TRANSCEND NHL 001. In the 68 patients treated with Breyanzi and evaluated for efficacy, 85.3% responded to treatment, with 67.6% achieving a complete response (CR). The median time to response was one month and the median duration of response was 13.3 months with a median follow-up of 22.2 months. More than half of responders remained in response at 12 months, and 38.8% of responders remained in response at 18 months.