Ipsen Withdraws Drug from Market After Potential Risks Outweigh Benefits
Ipsen announces the voluntary and immediate withdrawal of Tazverik (tazemetostat) from all markets where it is sold, across all indications. This decision follows emerging data from the SYMPHONY-1 phase Ib/III trial, which revealed a less favorable safety profile than expected.
Data Monitoring Committee Raises Concerns
The Independent Data Monitoring Committee (IDMC) of the SYMPHONY-1 trial indicated that, based on adverse events related to secondary hematologic malignancies, the risks could outweigh the potential benefits for patients in the therapeutic regimen evaluating tazemetostat in combination with lenalidomide and rituximab (R²) compared to R² alone in follicular lymphoma. The withdrawal affects both follicular lymphoma (FL) and epithelioid sarcoma (ES). Tazverik had received accelerated approval from the U.S. FDA in 2020 for these two indications.
Immediate Actions Taken in Clinical Trials
Ipsen has taken immediate action to discontinue treatment with tazemetostat for all patients currently enrolled in the SYMPHONY-1 trial. All participants will receive the standard treatment, namely lenalidomide plus rituximab only. The study will remain open, without new inclusions, to continue long-term safety follow-up of all participants. Ipsen is also discontinuing all active clinical trials and expanded access programs involving tazemetostat. The company is collaborating with the U.S. FDA to determine the next steps for the withdrawal and to provide all necessary information to finalize this process.
Financial Outlook Remains Unchanged
Ipsen states that the withdrawal should not impact the company's financial forecasts.
