FDA Issues Warning Regarding Risk of Secondary Primary Malignancies With Tazemetostat in Follicular Lymphoma, Epithelioid Sarcoma

SPMs With Tazemetostat in Follicular Lymphoma and Epithelioid SarcomaFollowing the voluntary withdrawal of indications for tazemetostat in follicular lymphoma and epithelioid sarcoma, the FDA issued an alert underscoring the risk of SPMs associated with tazemetostat treatment.In the SYMPHONY-1 trial, the rate of SPMs was 5.7% in patients treated with tazemetostat plus R2; no SPMs were reported in the control arm with placebo plus R2.Treatment with tazemetostat was halted in SYMPHONY-1, with all patients transitioning to treatment with R2 alone. The study remains open for long-term safety follow-up.