FDA Approves HEPZATO KIT for Adults Metastatic With Uveal Melanoma

Source: Targeted Oncology, August 2023

The first liver-directed therapy for the treatment of adult with metastatic uveal melanoma is now FDA approved.

  • Approval of Hepzato KIT marks the first approval of a liver-directed therapy for patients with metastatic uveal melanoma.
  • The Hepzato KIT is designed to aid doctors in conducting percutaneous hepatic perfusion.
  • Hepzato KIT includes an FDA box warning of possible toxicity related to the procedure.

The FDA has granted approval to the HEPZATO KIT (melphalan/Hepatic Delivery System [HDS]). This is a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) 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.