HUTCHMED's Tazemetostat NDA Accepted in China for Relapsed/Refractory Follicular Lymphoma with Priority Review

HUTCHMED (China) Limited announced on July 4, 2024, 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 and granted Priority Review by the China National Medical Products Administration (NMPA).

Tazemetostat is a groundbreaking methyltransferase inhibitor of EZH2, developed by Epizyme, Inc., which is now an Ipsen company. The drug has already received approval from the U.S. Food and Drug Administration (FDA) for treating specific patients with R/R FL and advanced epithelioid sarcoma (ES) under the FDA’s accelerated approval program. Additionally, it has been approved by the Japan Ministry of Health, Labour, and Welfare (MHLW) for certain patients with R/R FL. HUTCHMED has entered into a strategic partnership to research, develop, manufacture, and commercialize tazemetostat in China, Hong Kong, Macau, and Taiwan.

The China NDA for tazemetostat is supported by data from a multicenter, open-label, Phase II bridging study in China, as well as clinical trials conducted by Epizyme outside China. In May 2022, tazemetostat was approved for use in the Hainan Boao Lecheng International Medical Tourism Pilot Zone under the Clinically Urgently Needed Imported Drugs scheme for treating certain patients with ES and FL, consistent with the FDA-approved label. The drug also received approval in the Macau Special Administrative Region in March 2023 and in Hong Kong in May 2024.

Follicular lymphoma (FL) is a subtype of non-Hodgkin’s lymphoma (NHL), constituting approximately 17% of NHL cases. In 2020, there were an estimated 16,000 new cases of FL in China and 13,000 in the United States.

HUTCHMED's Phase II bridging study in China enrolled 42 patients. The primary objective was to assess the objective response rate (ORR) of tazemetostat in treating patients with R/R FL whose disease harbors EZH2 mutations. Secondary objectives included evaluating the duration of response (DoR), progression-free survival (PFS), overall survival (OS), safety, and pharmacokinetics of tazemetostat in patients with and without EZH2 mutations. The results of this study will be presented at an upcoming medical conference.

Additionally, HUTCHMED is participating in Ipsen’s SYMPHONY-1 study, leading it in China. This international, multicenter, randomized, double-blind, active-controlled, 3-stage, biomarker-enriched, confirmatory Phase Ib/III study aims to assess the safety and efficacy of tazemetostat in combination with rituximab and lenalidomide (R²) in patients with R/R FL after at least one prior line of therapy.

In the U.S., tazemetostat is indicated for treating adults and pediatric patients aged 16 years and older with metastatic or locally advanced ES not eligible for complete resection, adult patients with R/R FL with EZH2 mutations who have received at least two prior systemic therapies, and adult patients with R/R FL without satisfactory alternative treatment options. These indications are approved under the FDA's accelerated approval program based on ORR and DoR, with continued approval contingent on verification of clinical benefit in confirmatory trials.

The most common adverse reactions (≥20%) in patients with ES include pain, fatigue, nausea, decreased appetite, vomiting, and constipation. For patients with FL, common adverse reactions (≥20%) are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea, and abdominal pain.

Tazemetostat, marketed under the brand name TAZVERIK®, is also approved in Japan for treating relapsed or refractory EZH2 gene mutation-positive FL when standard treatments are not applicable. TAZVERIK® is a registered trademark of Epizyme Inc., an Ipsen company.

HUTCHMED is an innovative, commercial-stage biopharmaceutical company dedicated to discovering and globally developing targeted therapies and immunotherapies for cancer and immunological diseases. The company employs around 5,000 personnel, including approximately 1,800 in oncology/immunology, and has a track record of bringing cancer drug candidates from discovery to market.