FDA Approves Hepzato Kit as a Liver-Directed Treatment for Uveal Melanoma

The FDA approved Hepzato Kit (melphalan for Injection/Hepatic Delivery System) containing melphalan (Hepzato, Delcath Systems Inc.) as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues or lung that is amenable to resection or radiation.

Efficacy was evaluated in the FOCUS study, a single-arm,