Following the global launch of the first approved TIL cell therapy, lifileucel, the second CAR-T product in China for the treatment of multiple myeloma, Zevorcabtagene Autoleucel (赛恺泽), has finally received approval from the National Medical Products Administration (NMPA) for its new drug application to treat adult patients with relapsed or refractory multiple myeloma.
Hematological Neoplasms
In August 2023, the Department of Hematology at Nanfang Hospital, Southern Medical University, admitted a case of MM. The patient had relapsed after multiple lines of prior treatment and progressed to refractory MM with extramedullary disease.
Recently, Legend Biotech (NASDAQ: LEGN) announced in Somerset, New Jersey, that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (Ciltacabtagene Autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and are refractory to lenalidomide1.
In this dire situation, after a comprehensive evaluation by Professors Jin Jie and Yang Min’s team at the First Affiliated Hospital of Zhejiang University School of Medicine, they determined that CAR-T cell therapy was Mr.
In recent years, with the application of new treatment methods, the early mortality rate of multiple myeloma patients has been significantly reduced, and the prognosis of multiple myeloma patients has been improved. Early identification of multiple myeloma and precise risk stratification are crucial for treatment.
As of April 2024, the FDA has approved two CAR-T cell therapies for the treatment of multiple myeloma, Abecma (Idecabtagene vicleucel) and Carvykti (Ciltacabtagene Autoleucel, cilta-cel). Here is a brief introduction to these two CAR-T cell therapies.
On March 1, 2024, blood tumor patients welcomed another encouraging piece of news. China’s National Medical Products Administration (NMPA) officially issued a notification approving the New Drug Application (NDA) for Zevorcabtagene Autoleucel (CT053) injection, developed by Keymed Biosciences, for the treatment of relapsed or refractory multiple myeloma (approval date: February 23, 2024).
Equecabtagene Autoleucel injection (IASO Bio development code: CT103A; Innovent Biologics development code: IBI326) is an innovative CAR-T product targeting BCMA. In February 2023, the FDA granted this drug Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of relapsed/refractory multiple myeloma.
Carvykti® (cilta-cel, Ciltacabtagene Autoleucel) is the first CAR-T cell therapy to receive a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the second-line treatment of patients with relapsed or refractory multiple myeloma.