Ipsen, a Paris-based drugmaker, is removing its cancer drug Tazverik (tazemetostat) from the U.S. market because of safety concerns.
An ongoing Tazverik clinical trial has reported adverse events of secondary hematologic malignancies — which are blood cancers — indicating “the risks may outweigh potential benefits for patients,” Ipsen said in a March 9 news release.
The FDA granted Tazverik accelerated approval in 2020. The drug is approved to treat epithelioid sarcoma, a rare, aggressive soft tissue cancer that affects a few hundred patients each year, and relapsed or refractory follicular lymphoma, a form of non-Hodgkin lymphoma.
The company said it is voluntarily withdrawing Tazverik in all indications.