The Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued a positive opinion on the application for Orphan Drug Designation for ThermoDox®, a heat-activated liposomal encapsulation of doxorubicin, for the treatment of hepatocellular carcinoma. ThermoDox® is currently being evaluated in combination with radiofrequency ablation (RFA) vs. RFA alone in a phase III trial (the HEAT study) in 600 patients with non-resectable primary liver cancer.