Tazemetostat voluntarily withdrawn for FL

On March 9, 2026, tazemetostat, an enhancer of zeste homolog 2 (EZH2) inhibitor, was voluntarily withdrawn from all indications, including follicular lymphoma (FL). The decision was based on emerging data from the ongoing phase Ib/III SYMPHONY-1 study (NCT04224493), evaluating tazemetostat in combination with lenalidomide + rituximab (R²) vs R² alone as a second-line therapy for relapsed/refractory (R/R) FL. Results from SYMPHONY-1 were previously reported by the Lymphoma Hub. 

The withdrawal follows a recommendation from the independent data monitoring committee (IDMC), based on emerging data from SYMPHONY-1. Specifically, adverse events of secondary hematologic malignancies were observed, suggesting that the risks may outweigh the potential benefits for patients treated with this regimen. Steps have been taken to stop tazemetostat treatment for all patients currently enrolled in SYMPHONY-1; patients will receive standard of care (SoC) R² only. The study will continue, with no further enrollment, to assess long-term safety outcomes.