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Delcath Systems, Inc. Announces FDA Acceptance of New Drug Application Resubmission of Hepzato Kit with a PDUFA Date of August 14, 2023
NEW YORK, March 27, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and
About this update from Delcath Systems, Inc.
[{"type":"text","content":"NEW YORK, March 27, 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 the US Food and Drug Administration (FDA) has accepted Delcath Systems, Inc.'s (Delcath) new drug application resubmission for HEPZATO™ Kit (melphalan hydrochloride for Injection/Hepatic Delivery System) seeking approval for the treatment of patients with unresectable hepatic-dominant metastatic ocular melanoma (mOM). The FDA also communicated to Delcath that they consider the submission a complete class 2 response and the PDUFA date for the resubmission is August 14, 2023.\n\n \n \n \n \n \n \n\n \n\"The FDA's acceptance of the NDA resubmission is a significant milestone for Delcath and we look forward to working with the agency throughout its review of the application,\" stated Gerard Michel, Delcath's Chief Executive Officer. \"We believe that HEPZATO, if approved, will be an important option for treating patients with mOM.\"\nAbout the HEPZATO KitThe HEPZATO Kit is a drug-device combination product comprised of the drug (melphalan) and device (HDS) constituent parts. Melphalan is a well-established, broadly effective anticancer chemotherapeutic agent belonging to the alkylating class and is responsible for the combination product's primary mode of action. The procedure of surgical isolation and simultaneous filtration of hepatic venous blood during drug infusion and washout, known as percutaneous hepatic perfusion, or PHP, results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure relative to the comparable intravenous (IV) dose.\nIn the U.S., the efficacy and safety of Hepzato Kit have not been established for any indication and it is not presently approved by the FDA.\nAbout Delcath Systems, Inc.Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO™ KIT (melphalan hydrochloride for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP) are designed to administer high-dose chemotherapy to the liver while contr...