Immunotherapy for Patients With a Rare Form of Non-Hodgkin Lymphoma

The FDA has approved a CAR T-cell immunotherapy to treat certain adult patients with mantle cell lymphoma.

The U.S. Food and Drug Administration (FDA) has approved brexucabtagene autoleucel (Tecartus) to treat certain adult patients with relapsed or refractory mantle cell lymphoma (MCL).

Brexucabtagene autoleucel is a type of treatment that involves taking cells from a patient’s own immune system, engineering them in the lab, and then infusing them back into the patient’s body to identify and destroy cancer cells. 

Approval for this use of the therapy was based on an open-label, multicenter, single-arm trial involving 74 patients who previously received treatment with chemotherapy along with another form of immunotherapy and a targeted therapy. Among the 60 patients evaluable for efficacy after receiving brexucabtagene autoleucel, the overall response rate was 87 percent, with 62 percent having a complete remission.

Mantle cell lymphoma is a rare and fast-growing type of non-Hodgkin lymphoma that affects the B cells in the body’s immune system. The cancer begins in the lymph nodes and spreads to the spleen, bone marrow, blood, and sometimes the gastrointestinal system. It is among several subtypes of B-cell lymphomas that are estimated to account for five to six percent of the more than 77,000 cases of non-Hodgkin lymphoma diagnosed in the United States each year. 

The FDA granted brexucabtagene autoleucel accelerated approval on July 24, 2020. Accelerated approval means continued approval may be contingent upon a confirmatory trial.