BCMA CAR T-Cell Therapy Granted Priority Review for Multiple Myeloma
Posted: Tuesday, June 1, 2021
On May 26, the U.S. Food and Drug Administration (FDA) gave Priority Review designation to ciltacabtagene autoleucel, an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell therapy, for patients with relapsed and/or refractory multiple myeloma.
The FDA’s decision is based on efficacy and safety results from the open-label, multicenter phase IB/2 CARTITUDE-1 study. The study enrolled adults with relapsed and/or refractory multiple myeloma who received at least three prior lines of therapy or are double-refractory to a proteasome inhibitor and an immunomodulatory drug. All patients were administered a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. Researchers documented disease progression within 12 months of starting therapy. Future work in the upcoming phase II trial will evaluate the efficacy and overall response rate of ciltacabtagene autoleucel.
