FDA grants lisocabtagene maraleucel priority review for R/R CLL or SLL

On November 9, 2023, it was announced that the U.S. Food and Drug Administration (FDA) had granted lisocabtagene maraleucel, a chimeric antigen receptor T-cell therapy, priority review for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). This decision is based on promising results from the TRANSCEND CLL 004 (NCT03331198) trial.¹

TRANSCEND CLL 004

TRANSCEND CLL 004 is a phase I/II open-label study evaluating lisocabtagene maraleucel in patients with relapsed/refractory CLL/SLL.¹ The Lymphoma Hub previously reported the promising initial results at a median follow-up of 21 months which are summarized in Figure 1.²

Figure 1. Lisocabtagene maraleucel efficacy in patients with R/R CLL/SLL* 

CRi, complete response with incomplete hematologic recovery; ORR, overall response rate; uMRD, undetected minimal residual disease.
*Adapted from Siddiqi, et al.²