Hutchmed awarded NMPA conditional approval for Tazverik
The New Drug Application (NDA) for Tazverik (tazemetostat) has been granted conditional approval in China for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) with EZH2 mutation who have received at least two prior systemic therapies, said the drug’s developer, Chinese biopharma Hutchmed (HKEX: 13).
This approval follows the priority review status by the National Medical Products Administration (NMPA) and marks the first nationwide regulatory approval for Tazverik in China.
The conditional approval by the NMPA was supported by results from a multicenter, open-label, Phase II bridging study in China, and clinical studies conducted by Epizyme, s subsidiary of French drugmaker Ipsen (Euronext: IPN), outside China.
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