FDA Expects Decision on Cilta-cel Approval by February 2022

FDA Expects Decision on Cilta-cel Approval by February 2022

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FDA Expects Decision on Cilta-cel Approval by February 2022

The U.S. Food and Drug Administration (FDA) is expected to decide by the end of February whether or not to approve ciltacabtagene autoleucel, known as cilta-cel, an investigational CAR T-cell therapy for the treatment of relapsed or refractory multiple myeloma. The FDA extended its expected decision date to allow sufficient time to review information about an updated analytical method — which the FDA had requested and was recently submitted by the investigational therapy’s co-developers Legend…

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