French biopharmaceutical company Ipsen (Euronext Paris:IPN) (ADR:IPSEY) announced on Monday the voluntary withdrawal of Tazverik (tazemetostat) in all indications from all markets based on emerging safety data from the ongoing Phase Ib/III SYMPHONY-1 trial.

The study is evaluating tazemetostat in combination with lenalidomide and rituximab, versus lenalidomide plus rituximab, in follicular lymphoma. An Independent Data Monitoring Committee determined that adverse events involving secondary haematologic malignancies may outweigh the regimen's potential benefits.

The withdrawal applies to both follicular lymphoma and epithelioid sarcoma and takes effect immediately.

Ipsen has also begun stopping treatment with tazemetostat for all patients enrolled in the SYMPHONY-1 study, who will instead receive standard-of-care lenalidomide plus rituximab. The trial will remain open without further enrolment to support long-term safety follow-up, while the company is discontinuing all other active tazemetostat clinical trials and expanded access programmes.

Ipsen is coordinating with the US Food and Drug Administration (FDA) on the withdrawal process in the United States, where the drug received accelerated approval in 2020 for relapsed or refractory follicular lymphoma and for metastatic or locally advanced epithelioid sarcoma. The company said that the withdrawal is not expected to affect its financial guidance.