HUTCHMED (China) Limited has announced that the New Drug Application (NDA) for tazemetostat, aimed at treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), has been accepted for review by the China National Medical Products Administration (NMPA) and granted Priority Review status.
Tazemetostat, developed by Epizyme, now part of Ipsen, is a methyltransferase inhibitor targeting EZH2. It has already received approval from the U.S. Food and Drug Administration (FDA) for treating specific cases of R/R FL and advanced epithelioid sarcoma (ES) under an accelerated approval program.
Additionally, the Japan Ministry of Health, Labour and Welfare has approved it for certain R/R FL patients. HUTCHMED has a strategic partnership to advance the research, development, manufacturing, and commercialization of tazemetostat in China, Hong Kong, Macau, and Taiwan.
Support from Clinical Studies
The NDA submission in China is bolstered by data from a multicenter, open-label, Phase II bridging study conducted within the country, alongside clinical trials carried out by Epizyme internationally.
Tazemetostat had earlier been approved for use in the Hainan Boao Lecheng International Medical Tourism Pilot Zone in May 2022 for specific patients with ES and FL, consistent with FDA approvals. It was subsequently approved in Macau in March 2023 and in Hong Kong in May 2024.
Clinical Development in China
In China, 42 patients participated in the Phase II bridging study. The study's main goal was to assess the objective response rate (ORR) of tazemetostat in treating R/R FL patients with EZH2 mutations. Secondary objectives included evaluating the duration of response (DoR), progression-free survival (PFS), overall survival (OS), safety, and pharmacokinetics in patients regardless of their EZH2 mutation status. The study results are expected to be presented at an upcoming medical conference.
HUTCHMED is also leading Ipsen’s SYMPHONY-1 study in China, an international, multicenter, randomized, double-blind, active-controlled, 3-stage trial. This study aims to evaluate the safety and efficacy of tazemetostat combined with rituximab and lenalidomide (R²) in R/R FL patients who have undergone at least one prior line of therapy.
The acceptance of HUTCHMED's NDA for tazemetostat with Priority Review by the NMPA marks another milestone in advancing treatment options for R/R FL in China.
This development underscores the potential of tazemetostat as a promising therapy for patients battling this challenging condition.
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