Posted by Michael Wonder on 01 May 2021
Legend Biotech announces submission of European marketing authorisation application for BCMA CAR-T therapy ciltacabtagene autoleucel (cilta-cel) for the treatment of relapsed and/or refractory multiple myeloma
30 April 2021 - Submission follows accelerated assessment granted by the Committee for Medicinal Products for Human Use of the European Medicines Agency of the application based on positive Phase 1b/2 CARTITUDE-1 study data.
Legend Biotech announced today the submission of a marketing authorisation application to the EMA seeking approval of ciltacabtagene autoleucel for the treatment of patients with relapsed and/or refractory multiple myeloma.
