Accelerated assessment of cilta-cel announced by the EMA

The European Medicine Agency (EMA) has announced that the Committee for Medicinal Products for Human Use (CHMP) will undertake an accelerated assessment of the marketing authorization application (MAA) for ciltacabtagene autoleucel (cilta-cel; JNJ-68284528; LCAR-B38M) for use in patients with relapsed/refractory multiple myeloma (RRMM).¹ Cilta-cel is an investigational B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor T-cell (CAR T) product, with 4-1BB and CD3ζ costimulatory domains in addition to two anti-BCMA single-antibody domains.

This announcement follows the submission to the U.S. Food and Drug Administration (FDA) in December 2020 of a biologics license application (BLA).² The submission will be a rolling one, meaning that sections of the application, once completed, will be reviewed and submitted as part of an ongoing process.

The recent advances of cilta-cel in the regulatory path are supported by the results of the phase Ib/II CARTITUDE-1 trial (NCT03548207), which were presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition in 2020. An overall response rate of 96.9% was achieved, with 67% attaining a stringent complete response in heavily pretreated patients with MM.