Ipsen announced that it is voluntarily withdrawing Tazverik (tazemetostat) in all indications from all Ipsen markets. Ipsen’s decision to withdraw is based on emerging data from the ongoing phase-I(b)/III SYMPHONY-1 trial (evaluating tazemetostat in combination with lenalidomide plus rituximab (R2) vs R2 in Follicular Lymphoma (FL)). The Independent Data Monitoring Committee (IDMC) advised that, based on adverse events of secondary hematologic malignancies, the risks may outweigh potential benefits for patients within this treatment regimen. As a result of these data, Ipsen is withdrawing Tazverik effective immediately, including both for Follicular Lymphoma (FL) and Epithelioid Sarcoma (ES).

In addition to withdrawing Tazverik from the market, Ipsen has initiated steps to stop treatment with tazemetostat for all patients currently enrolled in the ongoing SYMPHONY-1 trial. All participants will receive standard of care, lenalidomide plus rituximab only. The study will remain open, with no further enrolment, to continue the long-term safety follow-up of all participants. Ipsen is also discontinuing all active tazemetostat clinical trials and expanded access programmes.

“While this is an extremely disappointing outcome, the safety of patients remains our priority. Emerging data from this confirmatory study have highlighted a safety profile that is unfavourable compared to that previously observed in clinical evaluation. We will now work closely with investigators and clinical teams to support patients through the respective next steps and transition plans,” said Christelle Huguet, PhD and EVP Head – R&D, Ipsen.

Ipsen is working with the US Food and Drug Administration (FDA) on the next steps to execute the withdrawal of Tazverik and provide all necessary information to complete this process. Tazverik is marketed in the US by Ipsen in FL and ES.

Tazverik received accelerated approval from the US FDA in 2020 for adults with relapsed or refractory FL whose tumours are positive for an EZH2 mutation and who have received at least two prior therapies as well as relapsed or refractory FL adult patients who have no satisfactory alternative treatment options. It also received US FDA accelerated approval in 2020 for the treatment of adults and adolescents aged 16 years and older with metastatic or locally-advanced epithelioid sarcoma not eligible for complete resection.

The withdrawal is not expected to impact the company’s financial guidance.