Melphalan for Injection-Hepatic Delivery System (Hepzato Kit)

General information

Class/mechanism: Nitrogen mustard, alkylator

Diseases for which it is established

• Uveal melanoma

History of changes in FDA indication

• 2023-08-14: Initial approval 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. (Based on FOCUS_HCC)

Also known as

• Brand name: Hepzato

References

1. FOCUS_HCC: NCT02678572