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JNJ / Legend Granted EU Accelerated Assessment for Cilta-cel; Can Cilta-cel’s MAA Submission Occur Before March 8, 2021?
On Monday, February 1, JNJ and Legend announced (press release) that the EMA granted cilta-cel (BCMA CAR-T) accelerated assessment for r/r MM. Management confirmed that they intend to file cilta-cel’s MAA during H1 2021. In case you missed it from January 25, Celltelligence revisits the likelihood of JNJ submitting an MAA by March 8, 2021 and cilta-cel’s potential regulatory timeline compared to ide-cel’s (BMS / bluebird).