Source: Healio News
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