Janssen and Legend Biotech’s BCMA-Targeted CAR-T Therapy Cilta-cel Granted FDA Priority Review for Relapsed/Refractory Multiple Myeloma

Today, Legend Biotech announced that the U.S. FDA has accepted the Biologics License Application (BLA) submitted by Janssen for ciltacabtagene autoleucel (cilta-cel), a CAR-T cell therapy targeting B-cell maturation antigen (BCMA). The FDA has also granted Priority Review designation for the application, with an expected action date by November 29 of this year.

Cilta-cel is a CAR-T cell therapy with a differentiated structure, comprising a 4-1BB costimulatory domain and two BCMA-targeting antibody domains, capable of promoting the expansion of CD8-positive T cells. BCMA is a protein highly expressed on myeloma cells. In December 2017, Janssen Biotech, Inc. and Legend Biotech entered into a global exclusive license and collaboration agreement to jointly develop and commercialize cilta-cel.

▲Schematic diagram of the structure of Cilta-cel (also known as JNJ-4528/LCAR-B38M) (Image source: Legend Biotech official website)

The regulatory submission for cilta-cel is based on the results of the pivotal phase 1b/2 CARTITUDE-1 study. Clinical data presented at the American Society of Hematology (ASH) Annual Meeting held last year demonstrated that cilta-cel continues to exhibit a very high overall response rate (ORR). At a median follow-up of 12.4 months, the ORR reached 97%, and with extended follow-up, the depth of response continued to deepen, with 67% of patients achieving a stringent complete response. Researchers will present updated long-term follow-up data at the American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #8005) and the European Hematology Association (EHA) Virtual Congress (Abstract #EP964) next month.

Note: The original text has been abridged.

References:

[1] U.S. Food and Drug Administration Grants BCMA CAR-T Cilta-cel Priority Review for the Treatment for Relapsed/Refractory Multiple Myeloma. Retrieved May 26, 2021, from https://www.businesswire.com/news/home/20210526006114/en

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