The National Medical Products Administration (NMPA) of China has approved CARsgen Therapeutics' new drug application for zevorcabtagene autoleucel to treat multiple myeloma.
The B cell maturation antigen (BCMA)-targeted autologous chimeric antigen receptor (CAR)-T product candidate is indicated to treat adults with relapsed or refractory multiple myeloma who have not responded to three lines of previous therapies.
The therapy involves modifying patients' T-cells to express a CAR that targets BCMA, a protein commonly found on the surface of multiple myeloma cells.
The cells are then infused back into the patient to attack and kill the cancer cells.
The approval is based on results from the LUMMICAR STUDY 1, a Phase II clinical trial conducted in China.
The multicentre open-label, single-arm trial demonstrated that zevorcabtagene autoleucel has "encouraging" efficacy and a favourable safety profile.
CARsgen is also conducting a separate Phase Ib/II LUMMICAR STUDY 2 in North America. This trial aims to assess the efficacy and safety of CAR-T therapy in the same patient population.
In 2019, the therapy received multiple designations from international regulatory agencies, including regenerative medicine advanced therapy and orphan drug designations from the US Food and Drug Administration.
The European Medicines Agency granted priority medicines and orphan medicinal product designations in 2019 and 2020 respectively.
The NMPA awarded zevorcabtagene autoleucel breakthrough therapy designation in 2020.
In a strategic move to facilitate the marketing of zevorcabtagene autoleucel in mainland China, CARsgen entered into a partnership with Huadong Medicine in January 2023.
Huadong Medicine gained sole rights to commercialise the CAR-T therapy within the territory.
CARsgen Therapeutics founder, board chairman, CEO and chief scientific officer Dr Zonghai Li stated: “We look forward to zevorcabtagene autoleucel bringing renewed hope to adult patients with relapsed or refractory multiple myeloma, thereby improving their survival.
“Guided by the vision of making cancer curable, we remain committed to exploring new technologies, expanding our product pipeline with global rights to address the major challenges of CAR T-cell therapies, and bringing innovative and differentiated cell therapies to cancer patients worldwide.”
