Lisocabtagene maraleucel granted FDA approval for the treatment of R/R CLL/SLL

On March 14, 2024, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.¹ Lisocabtagene maraluecel was previously granted priority review for this indication.

This approval is based on results from the phase I/II TRANSCEND CLL 004 trial (NCT03331198), which were previously covered by the Lymphoma Hub.¹ Briefly, the complete remission and overall response rates were 20% and 45%, respectively. The median duration of response among patients who achieved a complete remission was not reached. Lisocabtagene maraluecel comes with a boxed warning for cytokine release syndrome, neurologic toxicities, and secondary hematologic malignancies.¹