The Moffitt Cancer Center announced that the U.S. Food and Drug Administration (FDA) has approved melphalan for Injection/Hepatic Delivery System (Hepzato Kit)—a novel percutaneous hepatic perfusion therapy—to treat patients with ocular melanoma that has metastasized to the liver. The approval comes after results from the phase III FOCUS trial (ClinicalTrials.gov identifier NCT02678572) revealed that the response rate for patients undergoing percutaneous hepatic perfusion was 35.2% vs 12.5% among patients undergoing alternative therapy. The researchers also found that progression-free survival was 9.03 months in the percutaneous hepatic perfusion group vs 3.12 months for the alternative therapy group. “This is a breakthrough therapy that will help a patient population that has very few treatment options. The phase III trial was very positive in terms of overall response rate and durability of the responses, with very manageable toxicity,” concluded Jonathan Zager, MD, Chief Academic Officer and a surgical oncologist in the Department of Cutaneous Oncology at the Moffitt Cancer Center.
August 21, 2023