Ipsen SA voluntarily withdrew Tazverik (tazemetostat) from all markets worldwide, effective immediately, for both approved indications:
relapsed or refractory follicular lymphoma and epithelioid sarcoma.125
The decision followed an Independent Data Monitoring Committee review of the Phase Ib/III SYMPHONY-1 trial, which identified adverse events of secondary hematologic malignancies, indicating risks outweigh benefits.14
Ipsen shares dropped 3% following the announcement.1
The drug received accelerated FDA approval in 2020, contingent on confirmatory trial data like SYMPHONY-1.1
All tazemetostat treatments in SYMPHONY-1 are halted (patients switch to lenalidomide and rituximab), other trials and programs discontinued; withdrawal won't impact financial guidance.1
Ipsen is coordinating with the FDA on withdrawal steps.1
Sources:
1. https://www.investing.com/news/stock-market-news/ipsen-shares-drop-3-after-pulling-tazverik-over-blood-cancer-risk-4549089
2. https://www.marketscreener.com/news/ipsen-withdraws-cancer-drug-after-study-shows-unfavorable-safety-profile-ce7e5fd9dd8cfe2c
4. https://insights.citeline.com/scrip/therapeutic-category/anticancer/ipsen-to-pull-tazverik-following-safety-concerns-GTSOVNARXZGNFAO5REQ24WA3ZI/
5. https://www.marketscreener.com/news/ipsen-ce7e5fd9dd80f422