On January 30, Bristol-Myers Squibb (BMS) announced its CD19 CAR-T cell therapyBreyanzi（Lisocabtagene maraleucel，Liso-cel) Two supplemental Biologics License Applications (sBLA) have been accepted by the FDA for priority review, intended for the treatment of patients who have receivedBTK Inhibitor (BTKi) Treatment for Relapsed or Refractory Follicular Lymphoma (FL) and Mantle Cell Lymphoma (MCL) in Adult Patients, with PDUFA Dates of May 23, 2024, and May 31, 2024, Respectively.These two sBLAs are respectively based on Phase IITRANSCEND FLResearch and Phase IPositive results from the TRANSCEND NHL 001 study.TRANSCEND FLResearchIs aGlobal, Multicenter,Open-label,Single-armClinical trials,A total of 130 cases were included, all of whom had received at leastSecond-line treatmentRelapsed or Refractory IndolentBCellular Non-Hodgkin Lymphoma（NHL）Patients (including those with FL and marginal zone lymphoma), which is so far the largest clinical trial evaluating the efficacy of CAR-T cell therapy in such populations. The results showed, 101 evaluable patientsThe objective response rate (ORR) reached 97%, with a complete response (CR) rate as high as 94%.
TRANSCEND NHL 001 StudyIs aMulticenter,Open-label,Single-arm, seamless designA clinical trial enrolled a total of 88 patients who had received at least second-line treatment.Recurrent or RefractoryMCLPatient. The results showed,After receiving Breyanzi treatment, patients showed a statistically and clinically significant improvement in ORR (83.1%), with the majority (72.3%) achieving CR; the progression-free survival (PFS) was 15.3 months.Breyanzi was first approved for marketing in the United States in February 2021, forTreatment for relapsed or refractory patients who have received two or more systemic therapiesLarge B-Cell Lymphoma (LBCL)Adult patients, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B FL, unless otherwise specified.Copyright © 2024 PHARMCUBE. All Rights Reserved.
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