JW Therapeutics Announces Receipt of Breakthrough Therapy Designation for Carteyva® in Mantle Cell Lymphoma in China

04 April 2022 | Monday | News

JW Therapeutics (HKEx: 2126), an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China granted Breakthrough Therapy Designation for Carteyva® (relmacabtagene autoleucel injection) in patients with mantle cell lymphoma (MCL)
Image Source : Public Domain

Image Source : Public Domain

Carteyva® is an anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product independently developed by JW Therapeutics.

The Breakthrough Therapy Designation was supported by the results from the clinical study of Carteyva® in relapsed or refractory MCL (r/r MCL), which aimed to assess the efficacy and safety of Carteyva® in adults with r/r MCL in China. This is the first clinical result obtained in Chinese patients.

MCL is a non-Hodgkin lymphoma, which is highly aggressive and can't be cured by the currently approved therapies1. About 80% to 90% of MCL patients were diagnosed at the advanced stage and with poor prognoses2. Despite a few novel mechanism-of-action drugs such as Bruton tyrosine kinase inhibitors (BTKi) have improved outcomes for patients living with this disease, subsets of patients with aggressive disease biology or multiply relapsed disease continue to experience relatively poor outcomes with these currently available therapies. There are still urgent unmet medical needs to develop additional active therapeutic agents for the treatment of r/r MCL


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