By Fineline Cube 
China-based IASO Biotherapeutics announced that its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Fucaso (equecabtagene autoleucel), has received Orphan Drug Designation (ODD) from the Ministry of Food and Drug Safety (MFDS) of South Korea. 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.
Drug Profile
Fucaso is an innovative fully human anti-BCMA CAR-T cell therapy. It utilizes a lentivirus as a gene vector to transfect autologous T cells. The CAR construct includes a fully human single-chain variable fragment (scFv), CD8a hinge and transmembrane domains, and 4-1BB co-stimulatory and CD3ζ activation domains.
Regulatory Milestones
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. The ODD from South Korea’s MFDS further underscores its potential in addressing unmet medical needs in multiple myeloma.-Fineline Info & Tech