HEPZATO KIT

HEPZATO KIT is a combination product consisting of melphalan for injection and a proprietary Hepatic Delivery System (HDS). It is indicated 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. The kit delivers high-dose melphalan directly into the hepatic artery via percutaneous hepatic perfusion (PHP), saturating the liver while limiting systemic exposure through extracorporeal filtration. Melphalan acts as an alkylating agent by introducing interstrand cross-links into DNA, causing rapid and irreversible DNA damage leading to cancer cell death. The product was FDA approved in August 2023 based on phase 3 clinical trial data showing significant objective response rates in this patient population[1][2][3][6][8].

Brand names

HEPZATO KIT

Other names

Hepzatomelphalan hepatic delivery systemHepzato (melphalan) for injection/Hepatic Delivery System