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# Ipsen Withdraws Tazverik Over Safety Data
- URL: https://www.fdaweb.com/ipsen-withdraws-tazverik-over-safety-data/
- Published: 2026-03-09T12:00:00.000Z
- Updated: 2026-09-14T13:35:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160784

Ipsen is voluntarily withdrawing Tazverik (tazemetostat) from the market based on emerging data from the ongoing Phase 1b/3 SYMPHONY-1 trial that is evaluating the therapy in combination with lenalidomide plus rituximab in follicular lymphoma. The trial’s independent data monitoring committee advised that based on adverse events of secondary hematologic malignancies, the risks may outweigh potential benefits for patients within this treatment regimen. As a result of the data, Ipsen is withdrawing Tazverik effective immediately, including both for follicular lymphoma and epithelioid sarcoma.

In addition to withdrawing Tazverik from the market, Ipsen has initiated steps to stop treatment with tazemetostat for all patients currently enrolled in the ongoing SYMPHONY-1 trial. All participants will receive standard of care, lenalidomide plus rituximab only, according to the company.

“While this is an extremely disappointing outcome, the safety of patients remains our priority”, the company says. “Emerging data from this confirmatory study have highlighted a safety profile that is unfavorable compared to that previously observed in clinical evaluation. We will now work closely with investigators and clinical teams to support patients through the respective next steps and transition plans.”