Ipsen Withdraws Tazverik After SYMPHONY-1 Trial Flags Secondary Blood Cancer Risk; China Issues Class I Recall

Ipsen has announced the voluntary global withdrawal of Tazverik (tazemetostat) across all approved indications following emerging safety data from the ongoing SYMPHONY‑1 Trial. The decision follows a recommendation from the Independent Data Monitoring Committee after observing increased cases of secondary hematologic malignancies in patients receiving the drug as part of a combination regimen.

The safety signal emerged in the Phase Ib/III SYMPHONY-1 study (NCT04224493) evaluating tazemetostat in combination with lenalidomide and rituximab (R²) versus the standard R² regimen in patients with relapsed or refractory Follicular Lymphoma.

Based on the committee’s assessment that the risks may outweigh the potential benefits within this treatment setting, Ipsen has decided to withdraw the therapy effective immediately from all markets where it is available.

As part of the withdrawal, Ipsen has begun discontinuing treatment with tazemetostat for all patients currently enrolled in the SYMPHONY-1 trial. Participants will transition to the standard-of-care regimen consisting of lenalidomide plus rituximab alone.

While no further patient enrolment will occur, the study will remain open to enable long-term safety follow-up of existing participants.

The company also confirmed that all ongoing clinical trials and expanded access programs involving tazemetostat will be discontinued.

Christelle Huguet, PhD, Executive Vice President and Head of Research and Development at Ipsen, said the outcome is disappointing but emphasized that patient safety remains the company’s top priority. She noted that emerging data from the confirmatory trial revealed a safety profile that appeared less favorable than previously observed during earlier clinical development.

Ipsen is currently working with the U.S. Food and Drug Administration to complete the withdrawal process and provide all required regulatory information. According to the company, the decision is not expected to affect its financial guidance.

Tazverik originally received accelerated approval from the FDA in 2020 for multiple oncology indications. These included treatment of adults with relapsed or refractory follicular lymphoma whose tumors carry an EZH2 mutation after at least two prior therapies, as well as patients with relapsed or refractory follicular lymphoma lacking satisfactory treatment options. The drug was also approved for adults and adolescents aged 16 years and older with metastatic or locally advanced Epithelioid Sarcoma who were not eligible for complete surgical resection.

As an EZH2 inhibitor, tazemetostat works by targeting the enhancer of zeste homolog 2 (EZH2) enzymes, a histone methyltransferase involved in epigenetic regulation that can drive tumours growth in certain cancers. Its approvals were granted under the accelerated pathway based on response rates and duration of response, with confirmatory trials required to verify long-term clinical benefit.

The SYMPHONY-1 trial, launched as the required confirmatory study for follicular lymphoma, spans 229 clinical sites across 15 countries, including the United States, Europe, and China. The study evaluates outcomes in both EZH2-mutant and EZH2-wild-type patient populations.

Ipsen stated it will now work closely with investigators, clinical teams, and regulators to support patients during the transition and ensure appropriate follow-up care as the withdrawal is implemented globally.

 Note on Product Recall in China

Separately, Epizyme, the marketing authorization holder for tazemetostat hydrobromide tablets (Tazverik), has issued a voluntary product recall in China due to the emerging unfavorable benefit-risk profile.

The recall involves 200 mg Tazverik tablets (batch number: 3237911S) manufactured by Patheon Pharmaceuticals Inc. in Cincinnati, United States. The recall has been classified as a Class I drug recall, indicating a situation where the product may pose serious health risks.

Epizyme, working with its Chinese partner HUTCHMED, has initiated the immediate withdrawal and recall of the product from the Chinese market in accordance with local drug recall regulations.

Reference

Ipsen voluntarily withdraws Tazverik® (tazemetostat) in follicular lymphoma and epithelioid sarcoma, 09 March 2026, Ipsen voluntarily withdraws Tazverik® (tazemetostat) in follicular lymphoma and epithelioid sarcoma

A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination with Lenalidomide Plus Rituximab Versus Placebo in Combination with Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age with Relapsed/​Refractory Follicular Lymphoma. (SYMPHONY-1), ClinicalTrials.gov ID NCT04224493, https://clinicaltrials.gov/study/NCT04224493

Notice of Epizyme, Inc. voluntary product recall for Tazemetostat Hydrobromide Tablets (Tazverik®), Ipsen Announcement