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Hepzato (melphalan/Hepatic Delivery System) is a combination drug-device product developed by Delcath Systems for the treatment of liver-dominant cancers. It consists of melphalan hydrochloride, a well-established nitrogen mustard alkylating agent, and a proprietary Hepatic Delivery System (HDS). The HDS is used in a procedure called Percutaneous Hepatic Perfusion (PHP), which involves isolating the liver's blood flow to deliver high concentrations of chemotherapy directly to the organ while filtering the blood before it returns to the systemic circulation. This method allows for the administration of much higher doses of melphalan than would be possible through standard intravenous delivery, thereby increasing local efficacy while reducing systemic side effects. Hepzato is FDA-approved for metastatic uveal melanoma with liver involvement and is currently being evaluated in Phase 2 trials for liver-dominant metastatic breast cancer.
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