China-based IASO Biotherapeutics has 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 Health Sciences Authority (HSA) of Singapore. The therapy is intended for the treatment of relapsed/refractory multiple myeloma (R/R MM) in patients who have progressed after at least three lines of treatment.
Previous Approvals and Trials
Fucaso received its first market approval from China’s National Medical Products Administration (NMPA) on June 30, 2023, for treating R/R MM in patients who have undergone at least three lines of prior treatment. The therapy has also been cleared for trials in the United States.
Future Outlook
The acceptance of the NDA by the HSA marks a significant step for IASO Bio in expanding the reach of Fucaso to patients in need. With its innovative CAR-T platform and strong clinical performance, Fucaso is poised to address significant unmet needs in the treatment of multiple myeloma.-Fineline Info & Tech
