EMA Plans Speedy Review of Cilta-cel, CAR T-cell Therapy for Advanced Myeloma

EMA Plans Speedy Review of Cilta-cel, CAR T-cell Therapy for Advanced Myeloma

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EMA Plans Speedy Review of Cilta-cel, CAR T-cell Therapy for Advanced Myeloma

An accelerated review will be given an application for European Union approval of ciltacabtagene autoleucel (cilta-cel), a potential CAR T-cell therapy for heavily pre-treated multiple myeloma patients, its developer, Janssen, announced. An accelerated assessment, given to medications expected to have a major impact on public health, shortens the regulatory review process in Europe to 150 days from the standard 210 days. The decision to grant such a review is made by the Committee for Medicinal Products for Human…

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