Ipsen announced on Mar. 9 that it is voluntarily withdrawing its cancer drug Tazverik from the market following new safety concerns identified during an ongoing clinical study.
The decision comes after the Phase 1b/3 SYMPHONY-1 trial found that patients treated with a combination of Tazverik, lenalidomide, and Roche’s Rituxan experienced higher rates of secondary hematologic malignancies compared to those receiving only lenalidomide and Rituxan. An independent data board concluded that the risks associated with Tazverik may now outweigh its benefits, according to Ipsen's statement.
Tazverik was first approved in January 2020 for epithelioid sarcoma and later received approval for follicular lymphoma in June 2020. The SYMPHONY-1 trial focused on patients with follicular lymphoma. Ipsen said the withdrawal will affect both indications for Tazverik immediately.
All ongoing studies involving Tazverik, including SYMPHONY-1, are being terminated by Ipsen. Dosing has already begun to be discontinued, and all patients in these trials will transition to standard care while being monitored long-term for safety outcomes.
Christelle Huguet, Ipsen’s head of research and development, said SYMPHONY-1’s outcome was “extremely disappointing,” describing a “safety profile that is unfavorable compared to that previously observed.” She added that the withdrawal will not impact Ipsen’s financial guidance.
Looking ahead, Ipsen aims for 13% sales growth this year with a core operating margin above 35%, supported by several milestones such as potential European approval for Ojemda and late-stage data readouts for other drugs including Bylvay, Dysport, and Iqirvo. In 2025, cancer remained Ipsen’s largest revenue source with €2.545 billion in sales.
