HUTCHMED (00013) has announced an update regarding Tazverik® (tazemetostat). Tazverik® is an oncology therapy licensed from Epizyme, Inc., a company under Ipsen. Epizyme holds the marketing authorization for Tazverik® in mainland China, while Hutchison Whampoa Pharma (Shanghai) Co., Ltd., a subsidiary of HUTCHMED, acts as the designated local agent. Ipsen has informed HUTCHMED that it is voluntarily withdrawing Tazverik® from the U.S. market. Consequently, measures have been initiated to begin the market withdrawal and product recall process in China.
Hutchison Whampoa Pharma (Shanghai) Co., Ltd. has subsequently started the withdrawal and recall of the product in mainland China, Hong Kong, and Macau, and has halted all ongoing clinical trials involving tazemetostat. Current patients are advised to consult their treating physicians immediately to discuss alternative treatment options.
Ipsen is the sponsor of the ongoing SYMPHONY-1 Phase Ib/III study, which is evaluating tazemetostat in combination with lenalidomide and rituximab (the "R² regimen") compared to the R² regimen alone for treating follicular lymphoma. According to Ipsen's notification, the study's Independent Data Monitoring Committee, after reviewing recent data from the SYMPHONY-1 study, suggested that the potential risks of the treatment regimen, based on adverse events of secondary hematologic malignancies, may now outweigh the potential benefits for patients. Based on this data, Ipsen has decided to immediately withdraw Tazverik® from the market, including its indications for follicular lymphoma and epithelioid sarcoma.
In addition to the market withdrawal, Ipsen has initiated procedures to discontinue tazemetostat treatment for all patients in the SYMPHONY-1 study. All subjects will receive standard therapy (lenalidomide and rituximab only). The study will remain open to continue long-term safety follow-up for all subjects but will no longer enroll new patients. Ipsen is also stopping all ongoing tazemetostat clinical trials and expanded access programs. Ipsen is currently collaborating with the U.S. Food and Drug Administration (US FDA) to discuss next steps for executing the withdrawal and to provide all necessary information to complete the process.
Patient safety and well-being are paramount principles for HUTCHMED. Upholding this commitment, Hutchison Whampoa Pharma (Shanghai) Co., Ltd. has promptly notified healthcare professionals, the National Medical Products Administration (NMPA) of China, the Hong Kong Department of Health, and the Macau Health Bureau. Upon learning this information, Hutchison Whampoa Pharma (Shanghai) Co., Ltd. immediately placed a quarantine hold on the product inventory, suspended all sales and distribution, and notified medical institutions to stop prescribing and pharmacies to stop dispensing the product. The company also immediately instructed clinical trial sites in China to cease using tazemetostat. Furthermore, Hutchison Whampoa Pharma (Shanghai) Co., Ltd. is actively collaborating with regulatory authorities to determine the appropriate subsequent steps for the withdrawal and recall of Tazverik® in mainland China, Hong Kong, and Macau.
Tazverik® is a first-in-class EZH2 methyltransferase inhibitor developed by Epizyme. In the U.S., Tazverik® monotherapy was approved in 2020 through the US FDA's Accelerated Approval program. In China, Tazverik® received conditional approval from the NMPA as an imported drug for treating follicular lymphoma. This approval pathway incorporated an assessment of overseas clinical study data, considered approvals by foreign regulatory agencies, and included bridging study data to ensure the applicability of the overseas clinical trial results to the Chinese population. The continued registration of Tazverik® was subject to ongoing obligations, including reporting changes in its regulatory status abroad, emerging safety signals, and any new evidence that could impact the drug's benefit-risk profile for patients. This market withdrawal is not expected to impact the company's financial guidance. In 2025, sales of Tazverik® for HUTCHMED were $2.5 million.
Comments