Navigating the risks and benefits of newly approved Lisocabtagene Maraleucel in mantle cell lymphoma treatment.

Abstract

Mantle cell lymphoma (MCL) is a rare disorder that comprises 5-10% of non-Hodgkin's lymphoma, with an increasing incidence of about 1-2 cases per 100 000 people. It is characterized by cyclin D1 mutation. The intricate genomic landscape and cells' proliferation history contribute to its clinical heterogeneity. Multiple treatments often result in relapse and resistance owing to various mutations. To overcome the need for therapies in patients with relapsed/refractory (R/R) МСL, amidst increasing resistance to other treatment options, the Food and Drug Administration (FDA) approved Lisocabtagene Maraleucel (Lіѕо-Сеl) on 30 May 2024. In the clinical trial, Lisocabtagene Maraleucel showcased a high response rate and a manageable safety profile. However, severe adverse events were also observed, highlighting the need for risk and mitigation analysis before administration. Additionally, long-term studies evaluating its comparative efficacy and safety against existing therapies are needed, and more defined guidelines for managing high-risk patients are required.