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Cilta-Cel Reverts To Standard Review In EU

Janssen Says Loss Of Fast-Track Status For CAR-T Therapy Was Expected

Executive Summary

Janssen says the review at the European Medicines Agency of its marketing authorization application for cilta-cel reverted to standard timelines because the EMA wanted a GMP inspection and provision of a GMP certificate, "which did not allow continuation of the accelerated assessment timetable.”

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