Liso-Cel Approved for Refractory Large B-Cell Lymphoma

The FDA has approved lisocabtagene maraleucel (Breyanzi) for the treatment of adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least 2 other types of systemic treatment.

The FDA has approved lisocabtagene maraleucel (Breyanzi) for the treatment of adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least 2 other types of systemic treatment.

Each dose of the CAR T-cell product is developed using each patient's own T cells. The T cells are collected and genetically modified to comprise a new gene that facilitates targeting and elimination of lymphoma cells. Once the cells are modified, they are then infused back into the individual.

"Today's approval represents another milestone in the rapidly progressing field of gene therapy by providing an additional treatment option for adults with certain types of cancer affecting the blood, bone marrow, and lymph nodes," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, stated in a press release. "Gene and cell therapies have evolved from promising concepts to practical cancer treatment regimens."

Data from the phase 1 TRANSCEND NHL 001 trial showed that liso-cel resulted in an objective response rate of 73% and a CR rate of 53%, with the time to first complete response (CR) or partial response occurring at a median of 1 month.

The median duration of response has not been reached at a median follow-up of 12 months. Some 60.4% and 54.7% of patients remained in response at 6 and 12 months, respectively, lead study author Jeremy Abramson, MD, said when presenting the data at the 2019 ASH Annual Meeting.

This article was originally published on OncLive.com as, "FDA Approves Liso-Cel for Refractory Large B-Cell Lymphoma."