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  1. Drug Alerts and Statements

FDA Alerts Health Care Providers and Patients about Increased Risk of New Blood Cancers with Tazverik (tazemetostat) Use; Sponsor to Voluntarily Withdraw Product from Market

The U.S. Food and Drug Administration (FDA) is alerting patients and health care providers about the voluntary withdrawal of Tazverik (tazemetostat) tablets from the market due to an increased rate of hematologic second primary malignancies (SPMs) — the development of new blood cancers in people treated with Tazverik for a different cancer. As a result, it was determined that the risks of treatment with Tazverik outweigh its benefits.

Tazverik was approved in 2020 to treat individuals aged 16 years and older with metastatic or locally advanced epithelioid sarcoma (a rare cancer that starts as cell growth in the soft tissue) who are not eligible for complete resection. Later that year, it was approved to treat certain adults with relapsed or refractory follicular lymphoma, a slow-growing type of B-cell non-Hodkin lymphoma. FDA approved both indications under accelerated approval. At the time of accelerated approval, SPMs were recognized as a risk with Tazverik, with an incidence rate of 1.7%. However, with the Symphony 1 trial (NCT NCT04224493), the rate was found to exceed 5% over a median treatment duration of 15.8 months (range: 6.9 to 33 months).

An increased incidence of hematologic SPMs among people taking Tazverik was observed in the study, “SYMPHONY-1: A Phase 1b/3 Double-Blind, Randomized, Active-Controlled, 3-Stage, Biomarker Adaptive Study of Tazemetostat or Placebo in Combination with Lenalidomide Plus Rituximab in Subjects with Relapsed/Refractory Follicular Lymphoma.” In this study, as of March 6, 2026, 18 out of 318 (5.7%) patients treated with Tazverik developed hematologic SPMs, compared to no reported events among patients in the control arm. Most SPMs were myelodysplastic syndrome (MDS) and acute myeloid leukemia; others included B-cell acute lymphoblastic leukemia and clonal cytopenia of undetermined significance. Treatment-emergent acute leukemias and MDS are serious and life-threatening disorders that are not expected to be reversible, as evidenced by 3 deaths in the 18 patients, and 14 patients without resolution of the hematologic SPM.

Most participants who developed the new blood cancers were receiving Tazverik for 1-3 years. The SPMs started as early as 7.5 months after beginning treatment and occurred in some patients after stopping treatment. Based on these findings, an independent data monitoring committee recommended that enrollment on the SYMPHONY-1 trial should be stopped and that all patients receiving Tazverik should discontinue treatment immediately. Shortly thereafter, the sponsor, Ipsen, notified FDA of their plans to discontinue Tazverik treatment for patients in the clinical study and withdraw Tazverik from the U.S. market. The study will remain open for long-term safety follow-up of participants. All expanded access programs for Tazverik will be discontinued as well.

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