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FDA grants lisocabtagene maraleucel priority review for R/R CLL or SLL
By Sabina Ray
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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
- Business Wire. U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Breyanzi (lisocabtagene maraleucel) for relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). https://www.businesswire.com/news/home/20231109738749/en/U.S.-Food-and-Drug-Administration-Accepts-for-Priority-Review-Bristol-Myers-Squibb%E2%80%99s-Application-for-Breyanzi-lisocabtagene-maraleucel-for-Relapsed-or-Refractory-Chronic-Lymphocytic-Leukemia-CLL-or-Small-Lymphocytic-Lymphoma-SLL. Published Nov 9, 2023. Accessed Nov 10, 2023.
- Siddiqi T, Maloney D, Kenderian S, et al. Lisocabtagene maraleucel in chronic lymphocytic leukaemia and small lymphocytic lymphoma (TRANSCEND CLL 004): a multicentre, open-label, single-arm, phase 1–2 study. Lancet. 2023;402(10402):641-654. DOI: 1016/S0140-6736(23)01052-8
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