|
Hutchmed (China) Limited, an innovative, commercial-stage, biopharmaceutical company, announced an update regarding Tazverik (tazemetostat), an oncology therapy licensed from Epizyme, Inc. (Epizyme), an Ipsen (Ipsen) company, in China.
Epizyme is the marketing authorization holder of Tazverik in the Chinese mainland, for which Hutchmed Limited (a subsidiary of the company) acts as the domestic agent/licensee. Ipsen has informed Hutchmed that it is voluntarily withdrawing Tazverik in the US. As a result, steps have been taken to initiate the market withdrawal and product recall in China. Consequently, Hutchmed Limited has initiated a withdrawal and product recall from the Chinese mainland, Hong Kong and Macau, and is discontinuing all active tazemetostat clinical trials. Existing patients should consult their treating physicians immediately to discuss their treatment options.
Ipsen is the sponsor of the ongoing Phase Ib/III SYMPHONY-1 trial (evaluating tazemetostat in combination with lenalidomide plus rituximab (R²) vs R² in follicular lymphoma). As informed by Ipsen, following a review of emerging data from SYMPHONY-1, the study Independent Data Monitoring Committee advised that, based on adverse events of secondary hematologic malignancies, the risks may outweigh potential benefits for patients within this treatment regimen. As a result of these data, Ipsen is withdrawing Tazverik effective immediately, including both for follicular lymphoma (FL) and epithelioid sarcoma (ES).
Ipsen has announced that, in addition to withdrawing Tazverik from the market, Ipsen has initiated steps to stop treatment with tazemetostat for all patients currently enrolled in the ongoing SYMPHONY-1 trial. All participants will receive standard of care, lenalidomide plus rituximab only. The study will remain open, with no further enrollment, to continue the long-term safety follow-up of all participants. Ipsen is also discontinuing all active tazemetostat clinical trials and expanded access programs. Ipsen is working with the US Food and Drug Administration (FDA) on the next steps to execute the withdrawal of Tazverik and provide all necessary information to complete this process.
The safety and wellbeing of patients is Hutchmed’s top priority. In alignment with this commitment, Hutchmed Limited has promptly informed healthcare professionals, the China National Medical Products Administration (NMPA), the Hong Kong Department of Health and the Macau Health Bureau of this development. Upon becoming aware of this information, Hutchmed Limited immediately placed the product on hold, suspending all sales and shipments, and notified healthcare institutions to cease prescribing it and pharmacies to stop dispensing it. Hutchmed Limited has also immediately notified clinical trial sites in China to discontinue the use of tazemetostat. Furthermore, Hutchmed Limited is also actively cooperating with regulatory authorities to determine the appropriate next steps for the withdrawal and recall of Tazverik in the Chinese mainland, Hong Kong and Macau.
Tazverik is a first-in-class methyltransferase inhibitor of EZH2 developed by Epizyme. Tazverik monotherapy was approved by the US Food and Drug Administration in 2020 under the US Food and Drug Administration accelerated approval programme. Tazverik received conditional approval from the NMPA for the treatment of FL as an imported drug. This approval pathway incorporates the evaluation of overseas trial data, references overseas regulatory approvals, and bridging study data to adapt foreign trial results to the Chinese population. Continued registration of Tazverik is subject to continuing obligations, including reporting of changes in foreign regulatory status, new safety signals and new evidence affecting the benefit-to-risk profile to patients.
The withdrawal is not expected to impact the company’s financial guidance. In 2025, Hutchmed’s sales of Tazverik were US$2.5 million.
Hutchmed 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.
|