HUTCHMED Announces NMPA Conditional Approval for TAZVERIK® (tazemetostat) for the Treatment of Relapsed or Refractory Follicular Lymphoma
HUTCHMED (HCM) has received conditional approval from China's NMPA for TAZVERIK® (tazemetostat), marking its first approval in hematological malignancies. The drug is approved for treating adult patients with relapsed or refractory follicular lymphoma with EZH2 mutation who have received at least two prior systemic therapies.
The approval is based on a multicenter, open-label, Phase II bridging study in China and clinical studies conducted by Epizyme outside China. TAZVERIK® is the first and only EZH2 inhibitor approved by the NMPA and represents HUTCHMED's fourth approved product.
The ongoing SYMPHONY-1 study will serve as the confirmatory trial, evaluating TAZVERIK® in combination with rituximab and lenalidomide in R/R FL patients. HUTCHMED is responsible for research, development, manufacturing, and commercialization in China Mainland, Hong Kong, Macau, and Taiwan, while Epizyme remains the Marketing Authorization Holder in China.
HUTCHMED (HCM) ha ricevuto l'approvazione condizionata dalla NMPA cinese per TAZVERIK® (tazemetostat), segnando la sua prima approvazione nelle neoplasie ematologiche. Il farmaco è approvato per il trattamento di pazienti adulti con linfoma follicolare recidivante o refrattario con mutazione EZH2 che hanno ricevuto almeno due terapie sistemiche precedenti.
L'approvazione si basa su uno studio multicentrico, in aperto, di fase II condotto in Cina e su studi clinici realizzati da Epizyme al di fuori della Cina. TAZVERIK® è il primo e unico inibitore di EZH2 approvato dalla NMPA e rappresenta il quarto prodotto approvato da HUTCHMED.
Lo studio in corso SYMPHONY-1 fungerà da trial di conferma, valutando TAZVERIK® in combinazione con rituximab e lenalidomide nei pazienti con FL R/R. HUTCHMED è responsabile della ricerca, dello sviluppo, della produzione e della commercializzazione nella Cina continentale, a Hong Kong, Macao e Taiwan, mentre Epizyme rimane il titolare dell'autorizzazione al commercio in Cina.
HUTCHMED (HCM) ha recibido aprobación condicional de la NMPA de China para TAZVERIK® (tazemetostat), marcando su primera aprobación en malignidades hematológicas. El medicamento está aprobado para tratar a pacientes adultos con linfoma folicular en recaída o refractario con mutación EZH2 que han recibido al menos dos terapias sistémicas previas.
La aprobación se basa en un estudio multicéntrico, abierto, de fase II realizado en China y en estudios clínicos realizados por Epizyme fuera de China. TAZVERIK® es el primer y único inhibidor de EZH2 aprobado por la NMPA y representa el cuarto producto aprobado por HUTCHMED.
El estudio en curso SYMPHONY-1 servirá como el ensayo de confirmación, evaluando TAZVERIK® en combinación con rituximab y lenalidomida en pacientes con FL R/R. HUTCHMED es responsable de la investigación, desarrollo, fabricación y comercialización en China continental, Hong Kong, Macao y Taiwán, mientras que Epizyme sigue siendo el titular de la autorización de comercialización en China.
HUTCHMED (HCM)는 중국 NMPA로부터 TAZVERIK® (타제메토스타트)에 대한 조건부 승인을 받았으며, 이는 혈액암에서의 첫 번째 승인입니다. 이 약물은 최소 두 가지 이전 전신 요법을 받은 EZH2 변이가 있는 재발성 또는 불응성 성인 여포 림프종 환자를 치료하는 데 승인되었습니다.
승인은 중국에서 진행된 다기관, 공개 라벨, 2상 브리징 연구와 Epizyme이 중국 외부에서 수행한 임상 연구를 기반으로 합니다. TAZVERIK®는 NMPA에 의해 승인된 첫 번째이자 유일한 EZH2 억제제이며, HUTCHMED의 네 번째 승인 제품입니다.
진행 중인 SYMPHONY-1 연구는 확인 시험으로 기능하며, 재발성/불응성 FL 환자에서 rituximab 및 lenalidomide와 함께 TAZVERIK®을 평가합니다. HUTCHMED는 중국 본토, 홍콩, 마카오 및 대만에서 연구, 개발, 제조 및 상업화에 대한 책임이 있으며, Epizyme는 중국 내 마케팅 승인 보유자입니다.
HUTCHMED (HCM) a reçu une approbation conditionnelle de la NMPA en Chine pour TAZVERIK® (tazemetostat), marquant sa première approbation dans les malignités hématologiques. Le médicament est approuvé pour traiter des patients adultes atteints de lymphome folliculaire en rechute ou réfractaire avec mutation EZH2 ayant reçu au moins deux thérapies systémiques antérieures.
L'approbation repose sur une étude multicentrique, ouverte, de phase II réalisée en Chine et sur des études cliniques menées par Epizyme en dehors de la Chine. TAZVERIK® est le premier et l'unique inhibiteur d'EZH2 approuvé par la NMPA et représente le quatrième produit approuvé par HUTCHMED.
La récente étude SYMPHONY-1 servira d'essai de confirmation, évaluant TAZVERIK® en combinaison avec le rituximab et le lénaalidomide chez les patients R/R FL. HUTCHMED est responsable de la recherche, du développement, de la fabrication et de la commercialisation en Chine continentale, à Hong Kong, à Macao et à Taïwan, tandis qu'Epizyme reste le titulaire de l'autorisation de mise sur le marché en Chine.
HUTCHMED (HCM) hat von der NMPA in China eine bedingte Zulassung für TAZVERIK® (tazemetostat) erhalten, was die erste Zulassung für hämatologische Malignitäten darstellt. Das Medikament ist zur Behandlung von erwachsenen Patienten mit rezidivierendem oder refraktärem follikulärem Lymphom mit EZH2-Mutation zugelassen, die mindestens zwei vorherige systemische Therapien erhalten haben.
Die Zulassung basiert auf einer multizentrischen, offenen Phase-II-Brückenstudie in China und klinischen Studien, die von Epizyme außerhalb Chinas durchgeführt wurden. TAZVERIK® ist der erste und einzige EZH2-Inhibitor, der von der NMPA zugelassen wurde, und stellt das vierte genehmigte Produkt von HUTCHMED dar.
Die laufende SYMPHONY-1-Studie wird als Bestätigungsstudie dienen, die TAZVERIK® in Kombination mit Rituximab und Lenalidomid bei R/R FL-Patienten bewertet. HUTCHMED ist verantwortlich für Forschung, Entwicklung, Herstellung und Vermarktung im chinesischen Festland, Hongkong, Macao und Taiwan, während Epizyme der Inhaber der Marktzulassung in China bleibt.
- First and only EZH2 inhibitor approved in China, establishing market leadership
- Fourth product approval expands portfolio into hematological malignancies
- Strategic partnership with Epizyme provides commercialization rights in Greater China
- Conditional approval requires confirmatory trial results
- to patients with specific EZH2 mutation, restricting market size
- Requires at least two prior therapy failures, limiting eligible patient population
Insights
HUTCHMED's conditional approval for TAZVERIK® in China represents a strategic expansion of the company's product portfolio, marking its fourth approved drug and first entry into hematological malignancies. This diversification beyond solid tumors strengthens HUTCHMED's market position in China's oncology space.
As the first and only EZH2 inhibitor approved by China's NMPA, HUTCHMED secures a first-mover advantage with a novel mechanism of action. The approval for relapsed or refractory follicular lymphoma patients with EZH2 mutations who have received at least two prior therapies addresses a specific population with treatment options.
This milestone reflects the success of HUTCHMED's partnership strategy with Epizyme (now part of Ipsen), where HUTCHMED handles research, development, manufacturing, and commercialization across Greater China. The sequential approvals in the Hainan Pilot Zone (2022), Macau (2023), Hong Kong (2024), and now mainland China demonstrate systematic regional expansion.
Investors should note that this conditional approval requires confirmation through the ongoing SYMPHONY-1 study. This global Phase Ib/III trial evaluating TAZVERIK® in combination with rituximab and lenalidomide could potentially expand the drug's utility and strengthen its market position if results prove positive.
The NMPA's conditional approval of TAZVERIK® represents a significant therapeutic advance for Chinese patients with relapsed or refractory follicular lymphoma (FL) harboring EZH2 mutations. Follicular lymphoma, a common subtype of non-Hodgkin lymphoma, typically follows a relapsing course with increasingly shorter remission periods after each treatment line.
TAZVERIK®'s mechanism as an EZH2 inhibitor offers a precision medicine approach targeting a specific genetic alteration. EZH2 mutations occur in approximately 20% of FL cases and contribute to disease progression by altering gene expression patterns. By specifically inhibiting this enzyme, tazemetostat addresses a key driver of lymphoma cell growth in this subset of patients.
The approval's timing is critical - patients with FL who have failed two prior treatment lines typically face diminishing returns with conventional therapies. The principal investigator's comment about "poor outcomes" in this population underscores the unmet need TAZVERIK® addresses.
The confirmatory SYMPHONY-1 trial examining TAZVERIK® in combination with rituximab and lenalidomide (R²) carries significant clinical interest. This combination approach could potentially enhance efficacy by simultaneously targeting multiple disease pathways. While this approval focuses on a relatively narrow patient population, it represents an important new option for patients with alternatives.
— First and only EZH2 inhibitor approved by the NMPA —
— HUTCHMED’s fourth product, and its first approval in hematological malignancies —
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., March 21, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (“NDA”) for TAZVERIK® (tazemetostat) has been granted conditional approval in China for the treatment of adult patients with relapsed or refractory (“R/R”) follicular lymphoma (“FL”) with EZH2 mutation who have received at least two prior systemic therapies. This approval follows the priority review status by the National Medical Products Administration (“NMPA”) and marks the first nationwide regulatory approval for TAZVERIK® in China.
The conditional approval by the NMPA was supported by results from a multicenter, open-label, Phase II bridging study in China, and clinical studies conducted by Epizyme, Inc. (“Epizyme”), an Ipsen company, outside China. The primary objective of the bridging study is to evaluate the objective response rate (“ORR”) of TAZVERIK® for the treatment of patients with R/R FL whose disease harbor EZH2 mutations. The secondary objectives included duration of response (“DoR”), progression-free survival (PFS), and overall survival (OS) of TAZVERIK® for the treatment of R/R FL patients, as well as to evaluate the safety and pharmacokinetics. Additional details can be found at clinicaltrials.gov, using identifier NCT05467943.
“This approval represents a significant advancement in the management of this challenging disease. The majority of FL patients experience multiple relapses over their lifetime, posing substantial treatment difficulties and often leading to poor outcomes,” said Dr Junning Cao of Fudan University Cancer Center and the lead principal investigator of the bridging study. “TAZVERIK® has demonstrated promising efficacy in patients harboring EZH2 mutation in clinical trials. We are eager to provide this transformational epigenetic therapy to patients in China who have long sought new effective treatment options.”
“We are thrilled to be able to bring this innovative EZH2 inhibitor to patients in China. This approval highlights our dedication to addressing unmet medical needs not only through our internal pipeline, but also through partnering,” said Dr Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED. “It also marks our first approval in hematological malignancies, unveiling a new chapter for HUTCHMED as we extend our footprint into this disease area. As we move forward, we are dedicated to making this product available to R/R FL patients as soon as possible and will continue striving to make a meaningful impact on the lives of more patients suffering from devastating diseases.”
TAZVERIK® is a first-in-class methyltransferase inhibitor of EZH2 developed by Epizyme. It is approved by the US Food and Drug Administration (“FDA”) for the treatment of certain patients with R/R FL and certain patients with advanced epithelioid sarcoma (“ES”) 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. In 2021, HUTCHMED and Epizyme entered a strategic partnership. HUTCHMED is responsible for the research, development, manufacturing and commercialization of TAZVERIK® in China Mainland, Hong Kong, Macau and Taiwan. Epizyme will be the Marketing Authorization Holder of TAZVERIK® in China.
TAZVERIK® 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. TAZVERIK® was approved in Macau in March 2023 and in Hong Kong in May 2024.
The ongoing SYMPHONY-1 study will serve as the confirmatory trial to validate the clinical benefits of TAZVERIK®. SYMPHONY-1 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 TAZVERIK® in combination with rituximab and lenalidomide (R²) in patients with R/R FL after at least one prior line of therapy (NCT04224493). Epizyme is the sponsor of SYMPHONY-1 and HUTCHMED is leading the study in China.
About Follicular Lymphoma
FL is the second most common subtype of non-Hodgkin’s lymphoma (“NHL”), making up 20
About Tazemetostat approval in the United States and Japan
Tazemetostat 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 ES not eligible for complete resection.
- Adult patients with R/R FL 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 R/R FL who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval by the US FDA based on ORR and DoR. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
The most common (≥
Please see the US Full Prescribing Information for TAZVERIK® (tazemetostat).
TAZVERIK® is approved in Japan with the indication of relapsed or refractory EZH2 gene mutation-positive FL (only when standard treatment is not applicable).
TAZVERIK® is commercialized by Epizyme in the US and by Eisai in Japan.
TAZVERIK® is a registered trademark of Epizyme Inc., an Ipsen company.
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of tazemetostat for the treatment of patients with relapsed or refractory follicular lymphoma and the further clinical development of tazemetostat in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of clinical data to support NDA approval of tazemetostat for the treatment of patients with follicular lymphoma in China and other jurisdictions, the safety profile of tazemetostat, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for tazemetostat, and the timing of these events. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Medical Information
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
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1 NCCN Guidelines for Patients: Follicular Lymphoma. https://www.nccn.org/patients/guidelines/content/PDF/nhl-follicular-patient.pdf. Accessed February 17, 2025.
2 SEER Cancer Stat Facts: Follicular Lymphoma. National Cancer Institute. https://seer.cancer.gov/statfacts/html/follicular.html. Accessed February 17, 2025
3 The Global Cancer Observatory (GLOBOCAN), Cancer Today | IARC. https://gco.iarc.who.int/today/en/dataviz/bars?cancers=34. Accessed February 17, 2025.
FAQ
What is the significance of TAZVERIK's NMPA approval for HUTCHMED (HCM)?
What patient population can receive TAZVERIK (HCM) in China?
What clinical evidence supported TAZVERIK's approval for HCM in China?
Where else is TAZVERIK (HCM) currently approved?
