1 February 2021 - Janssen announced today that the CHMP of the EMA will perform an accelerated assessment of the marketing authorisation application for the B-cell maturation antigen targeted chimeric antigen receptor T-cell therapy ciltacabtagene autoleucel (cilta-cel).
Accelerated assessment is granted by the CHMP when a medicinal product is expected to be of major public health interest and therapeutic innovation and can significantly reduce the review timelines to evaluate a marketing authorisation application.