Hutchmed (China) Limited has announced that its New Drug Application (NDA) for TAZVERIK® (tazemetostat) has received conditional approval from the National Medical Products Administration (NMPA) in China. TAZVERIK® is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) harboring EZH2 mutations who have received at least two prior systemic therapies. This approval follows a priority review by the NMPA and marks the first nationwide regulatory approval for TAZVERIK® in China.
The approval is supported by positive results from a Phase II bridging study conducted in China and clinical studies conducted by Epizyme, Inc. ("Epizyme"), an Ipsen company, outside China. TAZVERIK® is a first-in-class methyltransferase inhibitor of EZH2 developed by Epizyme and is already approved by regulatory authorities in the US and Japan for the treatment of certain patients with FL and epithelioid sarcoma (ES).
TAZVERIK® has demonstrated promising efficacy in patients with EZH2 mutation, and its approval represents a significant advancement in the management of relapsed or refractory FL. HUTCHMED is responsible for the development and commercialization of TAZVERIK® in China Mainland, Hong Kong, Macau, and Taiwan, while Epizyme will be the Marketing Authorization Holder in China.
The ongoing SYMPHONY-1 study, an international Phase Ib/III trial, will serve as the confirmatory trial to validate the clinical benefits of TAZVERIK® in combination with other therapies for R/R FL.
This approval highlights HUTCHMEDs commitment to addressing unmet medical needs through internal pipeline development and partnerships, marking its first approval in hematological malignancies.