Ipsen Voluntarily Withdraws Tazverik

On March 9, 2026, Ipsen initiated a voluntary withdrawal of Tazverik® (tazemetostat) oral tablets from the US market, effective immediately, for all approved indications. The withdrawal was prompted by newly identified safety data from an ongoing study that demonstrated an imbalance in hematologic secondary malignancies, including cases suggestive of myelodysplastic syndrome (MDS) and acute leukemia. Tazverik is a methyltransferase inhibitor that received accelerated approval in 2020 for the treatment of adult patients who have relapsed or refractory follicular lymphoma (R/R FL) whose tumors are enhancer of zeste homolog 2 (EZH2) mutation positive and who have received at least two prior systemic therapies, as well as for adult patients who have R/R FL with no satisfactory alternative treatment options and adult and pediatric patients aged 16 years and older who have metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Following an ad hoc review by an Independent Data Monitoring Committee (IDMC), Ipsen determined that the potential risks of continued treatment may outweigh the clinical benefit in this setting and advised clinicians to immediately discontinue treatment and transition patients to alternative therapies, concurrent with trial enrollment suspension and market withdrawal across all indications. Ipsen stated that it will continue to evaluate the safety data in collaboration with regulatory authorities and will provide updates as additional information becomes available.