FDA Approves Melphalan Hepatic Delivery System for Adult Patients With Unresectable Hepatic-Dominant Metastatic Uveal Melanoma
Source: The Asco Post, September 2023
On August 14, the U.S. Food and Drug Administration (FDA) approved the HEPZATO KIT, a melphalan hepatic delivery system, as a liver-directed treatment for adult patients with metastatic uveal melanoma and 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.
HEPZATO KIT is a combination product that administers melphalan, a well-known and long-approved chemotherapeutic agent, directly to the liver through the novel hepatic delivery system, which permits higher drug exposure in target tissues while limiting systemic toxicity. The use of the hepatic delivery system allows practitioners to surgically isolate the liver while the hepatic venous blood is filtered during melphalan infusion and subsequent washout during a percutaneous hepatic perfusion procedure. Percutaneous hepatic perfusion results in locoregional delivery of a relatively high melphalan dose.
Metastatic uveal melanoma is a rare and aggressive form of metastatic cancer with an incidence of approximately 1,000 cases per year in the United States. Ninety percent of metastatic uveal melanoma cases involve the liver, and liver failure is often the cause of death. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend liver-directed therapies for patients with metastatic uveal melanoma and liver metastases. HEPZATO KIT is the only liver-directed therapy approved by the FDA for the treatment of metastatic uveal melanoma; percutaneous hepatic perfusion, the procedure enabled by HEPZATO KIT, is already included in the NCCN Guidelines.