Posted by Michael Wonder on 15 Aug 2023
Delcath Systems announces FDA approval of Hepzato Kit for the treatment of adult patients with unresectable hepatic dominant metastatic uveal melanoma
14 August 2023 - Hepzato Kit is the only FDA approved liver directed therapy to treat metastatic uveal melanoma.
Delcath Systems announced that today the US FDA approved Hepzato Kit (melphalan/hepatic delivery system) as a liver-directed treatment for adult patients with metastatic uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extra-hepatic disease, or extra-hepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.
