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HUTCHMED Announces Update on Licensed Oncology Product TAZVERIK® in China

  • HUTCHMED Limited has initiated a market withdrawal and product recall of TAZVERIK® (tazemetostat) in the Chinese mainland, Hong Kong, and Macau following a voluntary withdrawal announcement by Ipsen in the US.
  • The withdrawal is driven by a recommendation from the Independent Data Monitoring Committee for the SYMPHONY-1 trial, which determined that risks from secondary hematologic malignancies outweigh potential benefits.
  • TAZVERIK® is being withdrawn for both follicular lymphoma and epithelioid sarcoma indications in China.
  • All active tazemetostat clinical trials and expanded access programs are being discontinued, and existing patients are advised to consult physicians immediately for alternative treatment options.
  • The ongoing SYMPHONY-1 trial will stop tazemetostat treatment for enrolled participants, switching them to standard of care (lenalidomide plus rituximab only), though the study will remain open for long-term safety follow-up without further enrollment.
  • HUTCHMED has suspended all sales and shipments, instructed healthcare institutions to cease prescribing the drug, and notified the China NMPA, Hong Kong Department of Health, and Macau Health Bureau.
  • HUTCHMED stated that the withdrawal is not expected to impact the Company's financial guidance, noting 2025 sales of TAZVERIK® were US$2.5 million.
  • TAZVERIK® received conditional approval from the NMPA for follicular lymphoma treatment, with continued registration subject to reporting changes in foreign regulatory status and new safety signals.