Hutchmed (China) Limited has begun withdrawing the cancer therapy Tazverik (tazemetostat) from markets in mainland China, Hong Kong and Macau after its partner Ipsen decided to voluntarily remove the drug from the US market.

Tazverik, originally developed by Epizyme Inc.—now part of Ipsen—was marketed in mainland China with Hutchmed acting as the domestic licensee and agent. Following Ipsen’s decision, Hutchmed has initiated a product recall and suspended all sales and shipments of the therapy across the affected markets.

The company has also discontinued all ongoing clinical trials involving tazemetostat and advised patients currently receiving the treatment to consult their physicians regarding alternative therapy options.

The withdrawal follows safety concerns identified during the Phase Ib/III SYMPHONY-1 trial, which evaluated tazemetostat in combination with lenalidomide and rituximab for follicular lymphoma. According to Ipsen, the trial’s independent data monitoring committee flagged an increased risk of secondary hematologic malignancies, suggesting that the potential risks may outweigh the treatment benefits in this regimen.

As part of the response, Ipsen has stopped treatment with tazemetostat for all patients enrolled in the trial and halted further enrolment while continuing long-term safety monitoring. The company is also discontinuing all active clinical trials and expanded access programmes related to the drug and is working with the US Food and Drug Administration on the withdrawal process.

Hutchmed said it has informed relevant regulatory authorities, including the China National Medical Products Administration, the Hong Kong Department of Health and the Macau Health Bureau, and is cooperating with them on the next steps for the product recall.

Tazverik, an EZH2 methyltransferase inhibitor, received accelerated approval in the United States in 2020 and later obtained conditional approval in China for treating follicular lymphoma based on overseas clinical data.

Hutchmed noted that the withdrawal is not expected to affect its financial guidance, with Tazverik generating about USD 2.5 million in sales for the company in 2025.