FDA Green-Lights Phase III Trial for Drug-Eluting Microspheres in Liver Cancer

The FDA has given Merit Medical Systems the green light for a phase III clinical trial investigating QuadraSphere Microspheres in patients with primary liver cancer. The drug-eluting microspheres release doxorubicin to the tumor and are approved for peripheral arteriovenous malformations and to embolize hypervascular tumors. The phase III study will take place in the United States and abroad, enrolling only those patients whose liver disease is localized and unresectable.