China-based IASO Bio announced that a New Drug Application (NDA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy Fucaso (equecabtagene autoleucel) has been accepted for review by the Hong Kong Department of Health (DOH). The application is for the treatment of relapsed/refractory multiple myeloma (R/R MM) in patients who have progressed after at least three lines of treatment.
Drug Approval and Patient Treatment
Fucaso received its first market approval from China’s National Medical Products Administration (NMPA) on June 30, 2023, for use in treating R/R MM in patients who have undergone at least three lines of prior treatment. In December of the previous year, the first patient from Hong Kong was successfully treated with the drug, which was prepared by IASO Bio’s Nanjing manufacturing plant, at Queen Mary Hospital in Hong Kong. This event marks IASO Bio as the first cell therapy company from mainland China to complete real-world patient treatment under the Named Patient Program (NPP) in Hong Kong.-Fineline Info & Tech
