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An expert panel hosted by

The Lymphoma Hub logo and the Multiple Myeloma Hub logo

Sequencing immune-based therapies in B-cell malignancies

with Ulric Jäger, Sagar Lonial, and Krina Patel

Saturday, June 15 | 18:00-19:30 CEST

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

Nov 13, 2023
Learning objective: After reading this article, learners will be able to cite a new clinical development in lymphoma/CLL

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 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


  1. 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). Published Nov 9, 2023. Accessed Nov 10, 2023.
  2. 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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