US FDA accepts Delcath Systems' NDA resubmission of Hepzato Kit

Delcath Systems, Inc., an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announced that the US Food and Drug Administration (FDA) accepted Delcath'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 (mOM). The FDA also informed Delcath that the submission is a complete class 2 response and that the PDUFA date for the resubmission is August 14, 2023.

The FDA's acceptance of the NDA resubmission is a significant milestone for Delcath, and we look forward to working with the agency throughout the application's review," said Gerard Michel, Delcath's CEO. If Hepzato is approved, we believe it will be an important treatment option for patients with mOM." The Hepzato Kit is a drug-device combination product that includes both the drug (melphalan) and the device (HDS). Melphalan is a well-established, broadly effective anticancer chemotherapeutic agent of the alkylating class that is responsible for the primary mode of action of the combination product.

Percutaneous hepatic perfusion, or PHP, is a surgical isolation and simultaneous filtration of hepatic venous blood during drug infusion and washout that results in loco-regional delivery of a relatively high melphalan dose that can potentially induce a clinically meaningful tumour response with minimal hepatotoxicity and reduce systemic exposure relative to a comparable intravenous (IV) dose. In the US, the efficacy and safety of Hepzato Kit have not been established for any indication and it is not presently approved by the FDA. Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers.