JW Therapeutics’ CAR-T immunotherapy, Carteyva, has been approved for use in China.
The biotech company’s anti-CD19 cell therapy, otherwise called relmacabtagene autoleucel, can be now be used in adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL).
This follows its submission of a supplemental Biological License Application for the therapeutic, which went through the National Medical Products Administration (NMPA).
This is the third approval the CAR-T cell therapy has received, and it can currently be used to treat a range of haematological cancers.
The drug was previously granted Breakthrough Therapy Designation in early 2022, and then Priority Review in December 2023.
MCL is a type of B-cell non-Hodgkin lymphoma that is currently incurable, and is commonly associated with a poor prognosis.
There is a significant unmet need in this patient population, as there are little options available once a patient becomes refractory to first line treatments such as chemotherapy and BTK inhibitors.
Sophia Yang, Senior Vice President and Head of Regulatory, Research & Development of JW Therapeutics, noted: "We are delighted to have a product that can deliver meaningful efficacy in this disease, nearly 70% of patients with R/R MCL have achieved complete remission after treatment with Carteyva."
Additionally, the overall safety data demonstrated that the treatment was generally well-tolerated. Carteyva is first commercial CAR-T cell product for the treatment of R/R MCL in China."
