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HONG KONG - HUTCHMED (China) Limited (Nasdaq/AIM:HCM; HKEX:13) has received conditional approval from China’s National Medical (TASE:BLWV) Products Administration (NMPA) for TAZVERIK® (tazemetostat) to treat adult patients with relapsed or refractory follicular lymphoma. This marks the first approval in China for the EZH2 inhibitor and HUTCHMED’s inaugural venture into treatments for hematological malignancies.
The NMPA’s decision was influenced by a Phase II bridging study in China and additional clinical trials conducted outside of China by Epizyme (NASDAQ:EPZM), Inc., an Ipsen (EPA:IPN) company. The bridging study aimed to assess the objective response rate of TAZVERIK® in patients with the EZH2 mutation who have undergone at least two prior systemic therapies. Secondary objectives included evaluating the duration of response, progression-free survival, and overall survival, alongside the drug’s safety and pharmacokinetics.
Dr. Junning Cao, the lead principal investigator from Fudan University Cancer Center, emphasized the importance of this approval for patients who frequently face relapses and limited treatment options, leading to poor outcomes. TAZVERIK® has shown promising efficacy in clinical trials for patients with the EZH2 mutation.
Dr. Michael Shi, Head of R&D and Chief Medical Officer at HUTCHMED, expressed enthusiasm about bringing this novel therapy to patients in China and underscored the company’s commitment to addressing unmet medical needs.
TAZVERIK® has already been approved by the US Food and Drug Administration and the Japan Ministry of Health, Labour and Welfare for certain patients with relapsed or refractory follicular lymphoma. The SYMPHONY-1 study, a confirmatory trial to validate TAZVERIK®’s clinical benefits, is ongoing.
HUTCHMED is responsible for the research, development, manufacturing, and commercialization of TAZVERIK® in Mainland China, Hong Kong, Macau, and Taiwan, as per a strategic partnership with Epizyme in 2021. The drug was also approved for use in the Hainan Boao Lecheng International Medical Tourism Pilot Zone in May 2022, Macau in March 2023, and Hong Kong in May 2024.
Follicular lymphoma is the second most common subtype of non-Hodgkin’s lymphoma, accounting for 20-30% of all cases. In 2022, there were approximately 81,000 new cases in China and 78,000 in the United States.
This news is based on a press release statement.
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