By Fineline Cube 
China-based IASO Biotherapeutics announced that the New Drug Application (NDA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy Fucaso (equecabtagene autoleucel) has been approved by the Pharmaceutical Administration Bureau of the Macao Special Administrative Region (ISAF). This approval marks the first NDA approval for Fucaso outside of mainland China, allowing the drug to treat adult patients with relapsed or refractory multiple myeloma (R/RMM) who have received three or more lines of prior therapies, including at least one proteasome inhibitor and an immunomodulatory agent.
Clinical Trial Results
The approval was supported by results from the Phase I/II FUMANBA-1 study, which demonstrated the excellent efficacy and safety of Fucaso in treating R/RMM. The therapy has shown significant promise in addressing the unmet medical needs of patients with this condition.
Therapy Profile
Fucaso is an innovative fully human anti-BCMA CAR-T cell therapy. It uses lentivirus as a gene vector to transfect autologous T cells. The CAR construct includes a fully human scFv, CD8a hinge and transmembrane domains, and 4-1BB co-stimulatory and CD3ζ activation domains, designed to enhance therapeutic effectiveness and safety.
Regulatory Status
Fucaso was approved in mainland China in June 2023 for patients with R/RMM who have undergone at least three lines of prior treatment. The therapy is currently under regulatory review in Singapore and Hong Kong, highlighting IASO’s commitment to expanding access to this innovative treatment across Asia.-Fineline Info & Tech