By Fineline Cube 
China-based IASO Biotherapeutics announced that the Saudi Food and Drug Authority (SFDA) has granted Orphan Drug Designation (ODD) to its Fucaso (equecabtagene autoleucel), a BCMA-targeted chimeric antigen receptor (CAR) T cell therapy. The designation is for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
Fucaso Mechanism and Innovation
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 is designed with a fully human scFv, CD8a hinge and transmembrane domains, and includes 4-1BB co-stimulatory and CD3ζ activation domains. This advanced therapy aims to provide significant benefits for patients with R/R MM.
Regulatory Milestone
The drug received approval in mainland China in June 2023 for the treatment of R/R MM in patients who have undergone at least three lines of prior treatment. This milestone underscores IASO Biotherapeutics’ commitment to developing cutting-edge therapies for patients with significant unmet medical needs.-Fineline Info & Tech