NEW YORK – China's National Medical Products Administration on Friday approved Carsgen's autologous CAR T-cell therapy zevorcabtagene autoleucel as a fourth- or later-line treatment for multiple myeloma patients.
To be eligible for the B-cell maturation antigen (BCMA)-directed CAR T-cell therapy, patients must have received a prior immunomodulatory agent and proteasome inhibitor.
Chinese regulators approved the treatment after reviewing data from the single-arm Phase I/II LUMMICAR STUDY 1. According to data from this trial's initial part, zevorcabtagene autoleucel led to a 100 percent overall response rate in 14 patients and had an encouraging safety profile.
Carsgen inked a deal with Huadong Medicine in 2023, in which it granted Huadong Medicine exclusive rights to commercialize zevorcabtagene autoleucel in mainland China. Carsgen is still responsible for developing the treatment and securing regulatory approval.
The Shanghai-based company is also conducting a US-based trial of the cell therapy in multiple myeloma, dubbed LUMMICAR STUDY 2. In 2019, the US Food and Drug Administration granted the treatment regenerative medicine advanced therapy (RMAT) and orphan drug designation. The European Medicines Agency has also granted zevorcabtagene autoleucel priority medicines (PRIME) designation and orphan medicinal product designation.