FDA priority review granted for J&J, Legend Biotech’s myeloma CAR T therapy
CAR T therapy demonstrated an overall response rate of 97% in relapsed/refractory multiple myeloma patients after 12.4 months
Johnson & Johnson (J&J) and Legend Biotech’s CAR T therapy ciltacabtagene autoleucel has been granted a priority review by the US Food and Drug Administration (FDA) for the treatment of relapsed/refractory multiple myeloma.
The investigational B-cell maturation antigen (BCMA) CAR T therapy, also known as cilta-cel, is backed by results from the phase 1b/2 CARTITUDE-1 study.
This study is evaluating the safety and efficacy of cilta-cel in adults with relapsed/refractory multiple myeloma who have received at least three prior lines of therapy or who are double refractory to a proteasome inhibitor and immunomodulatory drug and an anti-CD38 antibody.
U S Food and Drug Administration Grants BCMA CAR-T Cilta-cel Priority Review for the Treatment for Relapsed/Refractory Multiple Myeloma
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