FDA grants priority review to liso-cel as a second-line therapy for R/R large B-cell lymphoma

On February 17, 2022, it was announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental biologics license application for lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, as a second-line therapy for relapsed or refractory (R/R) large B-cell lymphoma.¹ The U.S. FDA has assigned a target action date of June 24, 2022.

The application was based on the pivotal phase III TRANSFORM (NCT03575351) trial, in which liso-cel demonstrated significant and clinically meaningful improvements in event-free survival over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant. The latest results from this trial have been summarized on the Lymphoma Hub, check the visual abstract here.

Liso-cel has previously received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to treat adult patients with R/R diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma Grade 3B after two or more lines of systemic therapy.