FDA warns of secondary cancers linked to tazemetostat in follicular lymphoma and epithelioid sarcoma

The FDA issued an alert after the voluntary withdrawal of tazemetostat indications for follicular lymphoma and epithelioid sarcoma, emphasizing the drug's association with secondary primary malignancies.

In the SYMPHONY-1 trial, 5.7% of patients receiving tazemetostat combined with R2 developed secondary cancers, while no such events were reported in the placebo‑R2 arm.

Following the safety signal, the trial halted tazemetostat treatment and transitioned all participants to R2 alone, with the study remaining open for long‑term safety monitoring.