FDA Accepts Lisocabtagene Maraleucel for Priority Review for CLL, SLL

The US Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application for lisocabtagene maraleucel (Breyanzi) to expand its current indication to include the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who received a prior Bruton’s tyrosine kinase inhibitor (BTKi) and B-cell lymphoma 2 inhibitor (BCL2i).

Lisocabtagene maraleucel is a CD19-directed chimeric antigen receptor (CAR) T-cell therapy with a 4-1BB co-stimulatory domain, which enhances the expansion and persistence of the CAR T cells. It is made from a patient’s own T cells, which are collected and genetically reengineered to become CAR T cells that are delivered via infusion as a one-time treatment, according to the manufacturer of the drug.

The application was based on results from the primary analysis of the pivotal phase I/II, open-label, single-arm, multicenter TRANSCEND CLL 004 study, which were presented in an oral presentation during the 2023 ASCO^® Annual Meeting in June. TRANSCEND CLL 004 is the first pivotal multicenter study to show clinical benefit with a CD19-directed CAR T-cell therapy in patients with relapsed or refractory CLL after progression following treatment with a BTKi and BCL2i.

The FDA assigned a target action date of March 14, 2024.