HUTCHMED Announces China's Acceptance of Priority Review NDA for Tazemetostat in Treating Relapsed or Refractory Follicular Lymphoma

Thursday, July 04, 2024

HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) 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 and granted Priority Review by the China National Medical Products Administration (NMPA).

Tazemetostat, a pioneering methyltransferase inhibitor of EZH2, was developed by Epizyme, Inc., an Ipsen company. It is already approved by the U.S. Food and Drug Administration (FDA) for specific patients with R/R FL and advanced epithelioid sarcoma (ES) under the FDA’s accelerated approval program. Additionally, it has been approved by Japan's Ministry of Health, Labour and Welfare (MHLW) for certain patients with R/R FL. HUTCHMED has partnered strategically to research, develop, manufacture, and commercialize tazemetostat in China, Hong Kong, Macau, and Taiwan.

The NDA in China is supported by data from a multicenter, open-label, Phase II bridging study conducted in China and clinical studies carried out by Epizyme outside of China.

Tazemetostat was previously approved for use in the Hainan Boao Lecheng International Medical Tourism Pilot Zone in May 2022 under the Clinically Urgently Needed Imported Drugs scheme for treating certain patients with ES and FL, in line with the FDA-approved label. It received approval in the Macau Special Administrative Region (SAR) in March 2023 and the Hong Kong SAR in May 2024.

FL is a subtype of non-Hodgkin’s lymphoma (NHL), making up about 17% of NHL cases. In 2020, there were an estimated 16,000 new cases of FL in China and 13,000 in the U.S.

Tazemetostat, a groundbreaking methyltransferase inhibitor of EZH2 from Epizyme (an Ipsen company), is being developed, manufactured, and commercialized by HUTCHMED in China, Hong Kong, Macau, and Taiwan.

In the Phase II bridging study in China, 42 patients were enrolled to assess the objective response rate (ORR) of tazemetostat for treating patients with R/R FL who have EZH2 mutations. Secondary objectives included the duration of response (DoR), progression-free survival (PFS), overall survival (OS), safety, and pharmacokinetics in patients with R/R FL with or without EZH2 mutations. Study results will be presented at an upcoming medical conference (NCT05467943).

HUTCHMED is also leading Ipsen’s SYMPHONY-1 study in China. This international, multicenter, randomized, double-blind, active-controlled, 3-stage, biomarker-enriched, confirmatory Phase Ib/III study evaluates the safety and efficacy of tazemetostat in combination with rituximab and lenalidomide (R²) in patients with R/R FL after at least one prior therapy (NCT04224493).

Tazemetostat Approval in the United States

In the United States, tazemetostat is approved for:

• Adults and pediatric patients aged 16 and older with metastatic or locally advanced ES not eligible for complete resection.
• Adult patients with R/R FL whose tumors are EZH2 mutation-positive, as detected by an FDA-approved test, and who have received at least two prior systemic therapies.
• Adult patients with R/R FL who have no satisfactory alternative treatment options.

These indications are approved under accelerated approval by the U.S. FDA based on ORR and DoR. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. Common adverse reactions in patients with ES include pain, fatigue, nausea, decreased appetite, vomiting, and constipation. For patients with FL, common adverse reactions include fatigue, upper respiratory tract infection, musculoskeletal pain, nausea, and abdominal pain.

TAZVERIK® is also approved in Japan for relapsed or refractory EZH2 gene mutation-positive FL (only when standard treatment is not applicable). TAZVERIK® is a registered trademark of Epizyme Inc., an Ipsen company.

Source: globenewswire.com