On June 1, 2022 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that TAZVERIK (tazemetostat) has been approved by the Health Commission and Medical Products Administration of Hainan Province to be used in the Hainan Boao Lecheng International Medical Tourism Pilot Zone ("Hainan Pilot Zone"), under the Clinically Urgently Needed Imported Drugs scheme, for the treatment of certain patients with epithelioid sarcoma ("ES") and follicular lymphoma ("FL") consistent with the label as approved by the U.S. Food and Drug Administration ("FDA") (Press release, Hutchison China MediTech, JUN 1, 2022, View Source [SID1234615314]). Launched in 2013 and located in China, the Hainan Pilot Zone is a destination for international medical tourism and global hub for scientific innovation, welcoming 83,900 medical tourists in 2020, according to official data.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
TAZVERIK is a methyltransferase inhibitor of EZH2 developed by Epizyme, Inc. ("Epizyme"). It is approved by the FDA for the treatment of certain patients with ES and certain patients with FL under FDA accelerated approval granted in January and June 2020, respectively.
Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said: "The approval of TAZVERIK in the Hainan Pilot Zone allows patients to gain early access to this first-in-class EZH2 inhibitor in China, as part of our commitment to bringing innovative medicines to people in need. In addition to its use in the Hainan Pilot Zone, we also plan to initiate further registration-enabling studies in China under the terms of our agreement with Epizyme to facilitate wider and easier patient access."
In August 2021, HUTCHMED entered into a strategic collaboration with Epizyme to research, develop, manufacture and commercialize TAZVERIK in China, Hong Kong, Macau and Taiwan.
About FL and ES
Follicular lymphoma (FL) is a subtype of non-Hodgkin’s lymphoma ("NHL"). 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. ,,
Epithelioid sarcoma (ES) is a rare, slow-growing type of soft tissue cancer. Radical tumor resection is the primary treatment for patients with ES. However, ES is known for its high propensity for locoregional recurrence and distant metastases. The survival of patients with ES is often unsatisfactory with very limited treatment options.
About TAZVERIK (tazemetostat)
TAZVERIK is a methyltransferase inhibitor indicated in the United States for the treatment of:
Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval by the U.S. FDA based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
View the U.S. Full Prescribing Information here: www.tazverik.com
About Tazemetostat Clinical Development in China
HUTCHMED and Epizyme are developing tazemetostat in various hematological and solid tumors in Greater China, with HUTCHMED leading the China portion of Epizyme’s SYMPHONY-1 study. HUTCHMED and Epizyme also intend to conduct additional global studies jointly.
SYMPHONY-1 (EZH-302) is an international, multicenter, randomized, double-blind, active-controlled, 3-stage, biomarker-enriched, confirmatory Phase 1b/3 study, which is designed to evaluate the safety and efficacy of tazemetostat in combination with R² in patients with relapsed or refractory FL after at least one prior line of therapy(clinicaltrials.gov identifier: NCT04224493).
We intend to initiate a bridging study in FL to support registration of tazemetostat in China, as well as several combination studies of tazemetostat with HUTCHMED assets.