Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today that a Type II variation application was submitted to the European Medicines Agency (EMA) for CARVYKTI® based on data from the CARTITUDE-4 study (NCT04181827), which investigates the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received one to three prior lines of therapy. The submission was filed to the EMA by Janssen-Cilag International N.V., an affiliate of Janssen Biotech, Inc., Legend Biotech’s collaborator for the development and commercialization of cilta-cel.
Legend Biotech Announces Submission to the European Medicines Agency for Expanded Use of CARVYKTI® (ciltacabtagene autoleucel)
May 25, 2023
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