Tazverik Withdrawn From All Markets Over Safety Concerns

Ipsen, the maker of Tazverik (tazemetostat), announced March 9 that it is voluntarily withdrawing the drug from all markets worldwide after new data from an ongoing clinical trial raised safety concerns. The drug had been approved for adults with relapsed or refractory follicular lymphoma and for patients aged 16 and older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete surgical removal. The withdrawal is effective immediately and applies to all approved uses.

Christelle Huguet, Ipsen’s head of research and development, said the emerging data highlighted a safety profile that is less favorable than previously observed. “The safety of patients remains our priority,” she said. Ipsen plans to work closely with investigators and clinical teams to guide patients through next steps and transition plans. The company emphasized that patient support, communication, and monitoring will be central to the withdrawal process.

Data from symphony-1 trial

The withdrawal followed findings from the global phase 1b/3 SYMPHONY-1 trial, which evaluated Tazverik in combination with lenalidomide and rituximab for patients with relapsed or refractory follicular lymphoma. An independent data monitoring committee identified side effects involving secondary hematologic malignancies, also known as secondary blood cancers.

The committee concluded these risks may outweigh potential benefits for patients receiving the combination therapy. As a result, Ipsen has stopped treatment with Tazverik for all patients enrolled in the study. Patients will continue receiving lenalidomide plus rituximab without Tazverik. Long-term safety follow-up will continue for participants already in the trial. Enrollment of new patients has been halted to prevent additional risk.

Trial details and regulatory background

SYMPHONY-1 was designed as the confirmatory study required under the accelerated approval pathway for Tazverik’s follicular lymphoma indication. The drug initially received accelerated approval from the U.S. Food and Drug Administration (FDA) in 2020 for adults with relapsed or refractory follicular lymphoma who have an EZH2 mutation after at least two prior therapies, and for patients without satisfactory alternative treatment options.

Later in 2020, Tazverik also received accelerated approval for adults and children aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete surgical removal. Ipsen said it is discontinuing all other clinical trials and expanded access programs involving Tazverik. The company is working with the FDA to complete the withdrawal process and to ensure patients transition safely to alternative therapies. Investigators and clinical teams will provide guidance to support patients through treatment changes and ongoing care.

Safety and patient guidance

Patients who were receiving Tazverik should contact their oncology team immediately. Those enrolled in the SYMPHONY-1 trial will continue standard treatment with lenalidomide plus rituximab. Side effects reported in the trial included secondary blood cancers, which prompted the decision to stop the drug’s use.

Ipsen emphasized that patient safety was the primary reason for the withdrawal. Healthcare providers and patients will receive guidance on monitoring for long-term side effects and next steps for treatment. Long-term follow-up will continue for trial participants to track safety outcomes. Patients should work closely with their oncology teams to ensure they receive ongoing care and support while transitioning off Tazverik. Clear communication and coordinated care will help patients manage treatment safely during this change.

References

1. “Cancer Drug Tazverik Pulled Due to Safety Concerns” Ipsen. News Release. March 9, 2026.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI, reviewed by a human editor, but not independently verified by a medical professional.

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