The Pharmaceutical Administration Bureau of the Macao Special Administrative Region (ISAF) has approved equecabtagene autoleucel (FUCASO) for the treatment of adult patients with relapsed or refractory multiple myeloma including at least one proteasome inhibitor and an immunomodulatory agent.
The approval, which was announced on March 28, 2025, is based on the phase 1/2 FUMANBA-1 trial, which evaluated the therapy’s efficacy and safety in relapsed or refractory multiple myeloma patients who received three or more prior therapies, according to IASO Biotherapeutics, the manufacturer of the therapy.
Equecabtagene autoleucel is a fully human anti-B-cell maturation antigen chimeric antigen receptor T-cell therapy that uses a lentivirus as a gene vector to transfect autologous T cells.