Equecabtagene Autoleucel Injection Approved with Conditions by China NMPA
Recently, the Equecabtagene Autoleucel injection(Chinese trade name: 福可苏) of Nanjing IASO Biotechnology is approved with conditions through the priority review and approval procedure by China NMPA. It is indicated for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) after three or more prior lines of therapy and progressed, including a proteasome inhibitor and an immunomodulatory agent.
Equecabtagene Autoleucel Injection is an autologous cellular immunotherapy that involves integrating the chimeric antigen receptor (CAR) gene targeting B-cell maturation antigen (BCMA) into the patient's own peripheral blood CD3-positive T cells using a lentiviral vector. Once reinfused into the patient's body, these modified T cells recognize the BCMA target on the surface of multiple myeloma cells and kill them.
The approval of this product provides a novel treatment option for patients with relapsed or refractory multiple myeloma.