China’s National Medical Products Administration (NMPA) has granted conditional approval for Hutchmed’s Tazverik (tazemetostat) to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL) with enhancer of zeste homolog 2 (EZH2) mutation.
The decision is intended for individuals who have undergone a minimum of two previous systemic therapies.
Go deeper with GlobalData
This is the first regulatory approval for the therapy in China and comes after it gained NMPA’s priority review status.
Hutchmed chief medical officer and research and development (R&D) head Dr Michael Shi stated: “We are thrilled to be able to bring this innovative EZH2 inhibitor to patients in China. This approval highlights our dedication to addressing unmet medical needs not only through our internal pipeline, but also through partnering.
“As we move forward, we are dedicated to making this product available to R/R FL patients as soon as possible and will continue striving to make a meaningful impact on the lives of more patients suffering from devastating diseases.”
The conditional approval was based on the outcomes from the multicentre, open-label, Phase II bridging study in the country, alongside clinical trials conducted outside the country by Ipsen’s Epizyme, the developer of the therapy.
The bridging study’s main objective is to assess the objective response rate (ORR) of the therapy in treating subjects with R/R FL with EZH2 mutations.
Secondary objectives are progression-free survival, overall survival and duration of response, along with assessment of the therapy’s pharmacokinetics and safety.
Hutchmed and Epizyme entered a strategic collaboration in 2021, with the former taking on the responsibilities for the therapy’s research, development, manufacturing and commercialisation in mainland China, Macau, Taiwan and Hong Kong, while the latter holds marketing authorisation in the country.
In January 2025, the NMPA granted acceptance and priority review for the new drug application for Hutchmed’s Orpathys and Tagrisso combo, targeting individuals with locally advanced or metastatic non-small cell lung cancer.
