Oncology News Central (ONC)Tazemetostat Withdrawn Over Secondary Primary Cancer Risk

📋 Regulatory Action / Label Change

Ipsen voluntarily withdrew tazemetostat (Tazverik) in follicular lymphoma and epithelioid sarcoma after an independent data monitoring committee determined the risk-benefit profile had shifted unfavorably. The decision follows 18 hematologic second primary malignancies among 318 SYMPHONY-1 participants.

Professional Impact

• 5.7% of SYMPHONY-1 participants developed hematologic SPMs, most commonly myelodysplastic syndrome and acute myeloid leukemia
• Three participants died and 14 have unresolved hematologic SPMs; cases also occurred in patients who had stopped treatment
• SPMs appeared as early as 7.5 months after starting tazemetostat, with most affected patients having received the drug for one to three years
• The 2020 accelerated approvals covered relapsed/refractory EZH2-positive follicular lymphoma after two prior lines and metastatic or locally advanced epithelioid sarcoma ineligible for complete resection

Action Items

• Discontinue tazemetostat immediately in patients currently receiving it across both indications
• Transition SYMPHONY-1 participants to standard-of-care lenalidomide plus rituximab per the trial protocol update
• Establish long-term hematologic surveillance for previously exposed patients given delayed SPM onset
• Document the indication change in formulary and EHR prescribing systems