MAA filed for Legend Biotech and Janssen's for cilta-cell in Europe
Legend Biotech (Nasdaq: LEGN), a clinical stage CAR-T immuno-oncology biotech being spun out of Hong Kong-listed GenScript Biotech, revealed on Friday that a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMA) seeking approval of ciltacabtagene autoleucel (cilta-cel) for the treatment of patients with relapsed and/or refractory multiple myeloma.
The request was ma Publishde by Legend’s collaborator, Janssen Biotech, a part of US healthcare giant Johnson & Johnson (NYSE: JNJ). In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, to develop and commercialize cilta-cel, which involved an upfront payment of $350 million.
Cilta-cel is an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy being investigated as a treatment for multiple myeloma. The MAA is based on positive results from a Phase Ib/II CARTITUDE-1 study.
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