Ipsen is pulling its cancer drug Tazverik from all markets immediately, citing emerging safety data from an ongoing clinical trial that suggested the risks of the treatment may outweigh its benefits for patients.

Why is Tazverik being withdrawn?

The decision follows a review by the Independent Data Monitoring Committee (IDMC) overseeing the Phase Ib/III Symphony-1 trial, which was evaluating Tazverik in combination with lenalidomide and rituximab in patients with follicular lymphoma.¹

The IDMC identified adverse events involving secondary hematologic malignancies, new blood cancers arising in patients already being treated, and concluded that the risks of the combination regimen may outweigh its potential benefits.¹

Based on the clinical trial findings, Ipsen is withdrawing Tazverik across all indications, including both follicular lymphoma and epithelioid sarcoma, and is discontinuing all active tazemetostat clinical trials and expanded access programs.¹ The company is also working with the FDA to complete the formal withdrawal process in the U.S.

Christelle Huguet, executive vice president and head of R&D at Ipsen, called the outcome extremely disappointing but said patient safety had to take priority. "Emerging data from this confirmatory study have highlighted a safety profile that is unfavorable compared to that previously observed in clinical evaluation," she said.

What markets is Tazverik being withdrawn from?

With Ipsen working alongside FDA to complete a formal withdrawal in the U.S. market, Hutchmed Limited, a subsidiary company acting as the domestic agent/licensee of Tazverik in Mainland China, also announced it is formally withdrawing and recalling of Tazverik in Mainland China, Hong Kong, and Macau.²

With the safety and wellbeing of patients being Hutchmed’s top priority, the company has promptly informed healthcare professionals, the China National Medical Products Administration (“NMPA”), the Hong Kong Department of Health, and the Macau Health Bureau of the decision to recall and withdraw Tazverik from the market.²

Following Ipsen’s decsion in the U.S. market, Hutchmed immediately placed Tazverik on hold, suspending all sales and shipments, and notified healthcare institutions to cease prescribing it and pharmacies to stop dispensing it.²

Hutchmed has also immediately notified clinical trial sites in China to discontinue the use of tazemetostat, while also actively cooperating with regulatory authorities to determine the appropriate next steps for the withdrawal and recall of the treatment in the Chinese mainland, Hong Kong and Macau.²

What happens to patients currently on the drug?

Patients enrolled in the Symphony-1 trial are expected to be taken off tazemetostat and transitioned to the standard of care lenalidomide and rituximab alone.¹

The trial will remain open with no further enrollment in order to continue long-term safety follow-up for all participants, while Ipsen says it is working closely with investigators and clinical teams to support patients through the transition.

What was Tazverik approved for?

Tazverik, an EZH2 inhibitor, received accelerated FDA approval in 2020 for two indications: adults with relapsed or refractory follicular lymphoma whose tumors carry an EZH2 mutation and who had received at least two prior therapies, and adults and adolescents aged 16 and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.¹

Both approvals were granted under accelerated pathways based on response rate data, with continued approval contingent on confirmatory trial results, the same trial that has now prompted the withdrawal.

Ipsen says the decision is not expected to affect the company's financial guidance.¹

Sources

1. Ipsen voluntarily withdraws Tazverik® (tazemetostat) in follicular lymphoma and epithelioid sarcoma Ispen March 9, 2026 https://www.ipsen.com/press-release/ipsen-voluntarily-withdraws-tazverik-tazemetostat-in-follicular-lymphoma-and-epithelioid-sarcoma-3251503/
2. HUTCHMED Announces Update on Licensed Oncology Product TAZVERIK® in China Hutchmed March 9, 2026 https://www.globenewswire.com/news-release/2026/03/09/3251601/0/en/HUTCHMED-Announces-Update-on-Licensed-Oncology-Product-TAZVERIK-in-China.html