{"id":56912,"date":"2024-07-04T00:04:05","date_gmt":"2024-07-04T00:04:05","guid":{"rendered":"https:\/\/english.saigonbiz.com.vn\/2024\/07\/04\/hutchmed-announces-nda-acceptance-in-china-for-tazemetostat-for-the-treatment-of-relapsed-or-refractory-follicular-lymphoma-with-priority-review-status\/"},"modified":"2024-07-04T00:04:05","modified_gmt":"2024-07-04T00:04:05","slug":"hutchmed-announces-nda-acceptance-in-china-for-tazemetostat-for-the-treatment-of-relapsed-or-refractory-follicular-lymphoma-with-priority-review-status","status":"publish","type":"post","link":"https:\/\/english.saigonbiz.com\/vn\/hutchmed-announces-nda-acceptance-in-china-for-tazemetostat-for-the-treatment-of-relapsed-or-refractory-follicular-lymphoma-with-priority-review-status\/","title":{"rendered":"HUTCHMED Announces NDA Acceptance in China for Tazemetostat for the Treatment of Relapsed or Refractory Follicular Lymphoma with Priority Review Status"},"content":{"rendered":"
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HONG KONG and SHANGHAI and FLORHAM PARK, N.J., July 04, 2024 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (\u201cHUTCHMED<\/a>\u201d) (Nasdaq\/AIM:\u200bHCM; HKEX:\u200b13) today announces that the New Drug Application (\u201cNDA\u201d) for tazemetostat for the treatment of adult patients with relapsed or refractory (\u201cR\/R\u201d) follicular lymphoma (\u201cFL\u201d) has been accepted for review and granted Priority Review by the China National Medical Products Administration (\u201cNMPA\u201d).<\/p>\n

Tazemetostat is a first-in-class methyltransferase inhibitor of EZH2 developed by Epizyme, Inc. (\u201cEpizyme\u201d), an Ipsen company. Tazemetostat is approved by the U.S. Food and Drug Administration (\u201cFDA\u201d) for the treatment of certain patients with R\/R FL and certain patients with advanced epithelioid sarcoma (\u201cES\u201d) under the FDA accelerated approval program. It is also approved by the Japan Ministry of Health, Labour and Welfare (MHLW) for certain patients with R\/R FL. HUTCHMED entered into a strategic collaboration to research, develop, manufacture and commercialize tazemetostat in China, Hong Kong, Macau and Taiwan.<\/p>\n

This China NDA is supported by results from a multicenter, open-label, Phase II bridging study in China, and clinical studies conducted by Epizyme outside China.<\/p>\n

Tazemetostat was approved for use in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (Hainan Pilot Zone) in May 2022, under the Clinically Urgently Needed Imported Drugs scheme, for the treatment of certain patients with ES and FL consistent with the label as approved by the FDA. Tazemetostat was approved in the Macau Special Administrative Region (\u201cSAR\u201d) in March 2023 and in the Hong Kong SAR in May 2024.<\/p>\n

About Follicular Lymphoma<\/strong><\/p>\n

FL is a subtype of non-Hodgkin\u2019s lymphoma (\u201cNHL\u201d). FL accounts for approximately 17% of NHL. In 2020, there were an estimated 16,000 and 13,000 new cases of FL in China and the U.S., respectively.1<\/sup>,<\/sup>2<\/sup>,<\/sup>3<\/sup><\/p>\n

About Tazemetostat Clinical Development in China<\/strong><\/p>\n

Tazemetostat is a first-in-class methyltransferase inhibitor of EZH2 developed by Epizyme, an Ipsen company. HUTCHMED entered into a strategic collaboration to research, develop, manufacture and commercialize tazemetostat in China, Hong Kong, Macau and Taiwan.<\/p>\n

42 patients were enrolled in the Phase II bridging study in China. The primary objective was to evaluate the objective response rate (\u201cORR\u201d) of tazemetostat for the treatment of patients with R\/R FL whose disease harbor EZH2 mutations. The secondary objectives included duration of response (\u201cDoR\u201d), progression-free survival (PFS), overall survival (OS), safety and pharmacokinetics of tazemetostat for the treatment of R\/R FL patients whose disease do or do not harbor EZH2 mutations. Results of the study will be submitted for presentation at an upcoming medical conference (NCT05467943<\/a>).<\/p>\n

HUTCHMED is participating in Ipsen\u2019s SYMPHONY-1 study, leading it in China. This is an international, multicenter, randomized, double-blind, active-controlled, 3-stage, biomarker-enriched, confirmatory Phase Ib\/III study, which is designed to evaluate the safety and efficacy of tazemetostat in combination with rituximab and lenalidomide (R\u00b2) in patients with R\/R FL after at least one prior line of therapy (NCT04224493<\/a>).<\/p>\n

About Tazemetostat approval in the United States<\/strong><\/p>\n

Tazemetostat is a methyltransferase inhibitor indicated in the United States for the treatment of:<\/p>\n