China-based HutchMed (NASDAQ: HCM, HKG: 0013) has announced receiving conditional marketing approval from the National Medical Products Administration (NMPA) for its drug Tazverik (tazemetostat), an EZH2 methyltransferase inhibitor. The approval allows Tazverik to treat relapsed or refractory (R/R) follicular lymphoma (FL) with EZH2 mutations in patients who have previously received at least two systemic therapies.
Approval Background and Significance
The approval was awarded priority review status by the NMPA in July of last year. This marks a significant milestone for HutchMed in expanding its oncology portfolio in China, addressing an unmet medical need for patients with specific lymphoma indications.
Drug Development and Licensing
Developed by Epizyme, Inc., a unit of Ipsen, Tazverik was granted accelerated approval in the US in January and June of 2020 for treating advanced epithelioid sarcoma and R/R FL, respectively, followed by marketing approval in Japan. HutchMed entered into a licensing deal with Ipsen in 2021, acquiring the rights to research, develop, manufacture, and commercialize Tazverik in mainland China, Hong Kong, Macau, and Taiwan.-Fineline Info & Tech
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