Dr. Abramson on the FDA Approval of Liso-Cel in Refractory Large B-Cell Lymphoma

Jeremy S. Abramson, MD, director, Jon and JoAnn Hagler Center for Lymphoma, Massachusetts General Hospital, associate professor of medicine, Harvard Medical School, discusses the FDA approval of lisocabtagene maraleucel (liso-cel; Breyanzi) in refractory large B-cell lymphoma.

On February 5, 2021, the FDA approved liso-cel 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 approval of the CD19-directed product offers another highly effective option to patients, says Abramson.

The regulatory decision was based on findings from the phase 1 TRANSCEND NHL 001 trial in which liso-cel induced an objective response rate of 73% and a complete response rate of 53% in patients with heavily pretreated large B-cell lymphoma. Moreover, the median time to first complete response or partial response was 1 month, suggesting patients can obtain rapid responses with liso-cel, explains Abramson. The median duration of response had not yet been reached at a median follow-up of 12 months, concludes Abramson.