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EU CHMP recommends approval of Cilta-cel for multiple myeloma.- Janssen Pharma

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Published:26th Mar 2022

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorisation of Cilta-cel (ciltacabtagene autoleucel) for the treatment of adults with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

 

The positive CHMP Opinion is supported by data from the pivotal CARTITUDE-1 study. Results from the study were presented at the American Society of Hematology (ASH) 2021 Annual Meeting (Abstract #549). This CHMP Opinion follows the recent approval of cilta-cel by the United States (U.S.) Food and Drug Administration (FDA) in February 2022.

Condition: Multiple Myeloma
Type: drug

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