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Delcath Systems, Inc. Announces FDA Approval of HEPZATO KIT™ for the Treatment of Adult Patients with Unresectable Hepatic-Dominant Metastatic Uveal Melanoma
HEPZATO KIT is the only FDA approved liver-directed therapy to treat metastatic uveal melanoma Approval includes treatment naïve and previously treated
About this update from Delcath Systems, Inc.
[{"type":"text","content":"HEPZATO KIT is the only FDA approved liver-directed therapy to treat metastatic uveal melanoma \nApproval includes treatment naïve and previously treated patients and is not limited by HLA genotype\nDelcath to hold Business Update Call on August 15, 2023 at 8:00 a.m. Eastern Time\nNEW YORK, Aug. 14, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that today the US Food and Drug Administration (FDA) approved HEPZATO KIT (melphalan/Hepatic Delivery System) as 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.\n\n \n \n \n \n \n \n\n \nmUM is a rare and aggressive form of metastatic cancer with a US incidence of approximately 1,000 cases per year. Ninety percent of mUM involves the liver, and liver failure is often the cause of death. National Comprehensive Cancer Network (NCCN) guidelines recommend liver-directed therapies for mUM patients with liver metastases. HEPZATO KIT is the only liver-directed therapy approved by the FDA for the treatment of mUM and percutaneous hepatic perfusion (PHP), the procedure enabled by HEPZATO KIT, is already included in the NCCN guidelines.\n\"FDA approval of HEPZATO KIT marks the beginning of a new chapter for Delcath and the culmination of the Company's commitment to bring this treatment option to patients suffering from metastatic uveal melanoma,\" said Gerard Michel, Delcath's Chief Executive Officer. \"We look forward to partnering with cancer centers across the country to build a network of treatment sites trained in the use of this novel therapy.\"\nThe Company plans to have commercial product available in the fourth quarter, and patients will continue to be enrolled and treated at Expanded Access Program (EAP) sites.\nThe approval of HEPZATO KIT was based primarily on the results of the FOCUS Study (NCT02678572), a Phase 3, single arm, multicenter, open label study, which administered HEPZATO (melphalan) via the hepatic delivery system (HDS) during a PHP procedure. Ninety-one (91) patients received tr...