Ipsen will withdraw Tazverik’s follicular lymphoma and epithelioid sarcoma indications as emerging data point to an elevated safety risk in patients undergoing treatment.
Ipsen is voluntarily withdrawing the methyltransferase inhibitor Tazverik from the market after an ongoing clinical study detected secondary hematologic malignancies in patients treated with a regimen that included the drug.
In the Phase 1b/3 SYMPHONY-1 trial, patients treated with Tazverik, lenalidomide and Roche’s Rituxan showed higher rates of such malignancies than those on lenalidomide plus Rituxan alone. Because of this safety signal, an independent data board found that the risks of taking Tazverik may now outweigh its benefits, according to a company release on Monday.
First approved in January 2020 for epithelioid sarcoma, Tazverik is a small-molecule drug that works by blocking the methyltransferase enzyme, which in cancer has been linked to a tumor’s growth, metastasis and ability to evade the immune system. In June 2020, just months after its initial approval, Tazverik picked up another indication, this time for follicular lymphoma. SYMPHONY-1 was conducted in patients with follicular lymphoma.
Monday’s withdrawal will affect both of Tazverik’s indications “effective immediately,” the biotech said in its press announcement.
Ipsen is also terminating all ongoing studies of Tazverik, including SYMPHONY-1, in which the biotech has started discontinuing dosing. All patients in the trial will receive standard of care and will be followed long-term to assess safety.
Christelle Huguet, the company’s head of R&D, called SYMPHONY-1’s outcome “extremely disappointing,” having painted a “safety profile that is unfavorable compared to that previously observed.” Nevertheless, Tazverik’s exit from the market will not affect Ipsen’s financial guidance.
In its full-year 2025 report last month, Ipsen announced that it aims to hit 13% sales growth this year, with core operating margin above 35%. To meet this target, the biotech is relying on five major milestones this year, including a potential European approval for its oral kinase inhibitor Ojemda for pediatric low-grade glioma.
Other key 2026 catalysts for the Ipsen include Phase 3 readouts for Bylvay, indicated for itching in progressive familiar intrahepatic cholestasis, and Dysport, approved for frown lines. Ipsen is also looking ahead to late-stage data for the primary biliary cholangitis drug Iqirvo.
Cancer continued to be Ipsen’s biggest cash-maker in 2025, with sales growing 4.1% year-on-year to hit €2.545 billion (around $2.94 billion), while its rare disease portfolio surged 102.5% to reach €384 million (roughly $445 million).
