FDA delays decision on ciltacabtagene autoleucel CAR-T for advanced multiple myeloma
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The FDA has delayed its decision on a biologics license application for ciltacabtagene autoleucel, a chimeric antigen receptor T-cell therapy for treatment of adults with relapsed or refractory multiple myeloma.
Ciltacabtagene autoleucel (Janssen, Legend Biotech) — often called cilta-cel — is an autologous, gene-edited CAR T-cell therapy that targets the B-cell maturation antigen on the surface of cancer cells.
The FDA initially set a target action date of Nov. 29. The agency extended that until Feb. 28, 2022, so it can review additional information it requested regarding “an updated analytical method,” according to a Janssen-issued press release.
Cilta-cel, which is being evaluated as part of the FDA’s priority review program, previously received breakthrough therapy designation.
If approved, the agent would become the second BCMA-directed CAR T-cell therapy available for commercial use in the United States.
The BLA is based on results of the phase 1b/phase 2 CARTITUDE-1 trial. Data presented at this year’s ASCO Annual Meeting showed an overall response rate of 97.9% — including a stringent complete response rate of 80.4% — among 97 patients treated with a single dose of cilta-cel.
Reference:
Usmani SZ, et al. Abstract 8005. Presented at: ASCO Annual Meeting (virtual meeting); June 4-8, 2021.
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