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Delcath Systems Announces New Drug Application Resubmission for HEPZATO Kit
NEW YORK, Feb. 14, 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, Feb. 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 it submitted a new drug application (NDA) resubmission to the US Food and Drug Administration (FDA) for the HEPZATO™ Kit (melphalan hydrochloride for Injection/Hepatic Delivery System or Melphalan/HDS) seeking approval for the treatment of patients with unresectable hepatic-dominant metastatic ocular melanoma (mOM).\n\n \n \n \n \n \n \n\n \nThe resubmission is in response to a September 12, 2013 Complete Response Letter (CRL) from the FDA. The NDA resubmission contains comprehensive data and information to address all issues identified in the CRL. The FDA is expected to determine whether the resubmission constitutes a complete response and is eligible for review within 30 days. Once accepted for review by the FDA, a new PDUFA action date will be established for the HEPZATO Kit application.\n\"The submission is a critical milestone for Delcath and represents the culmination of years of work by investigators and employees,\" said Gerard Michel, CEO of Delcath. \"We look forward to receiving feedback from the FDA regarding a PDUFA date within 30 days.\"\nAbout the FOCUS Trial \nThe FOCUS trial evaluated the safety and efficacy of treatment with HEPZATO Kit for patients with mOM. The primary endpoint of Overall Response Rate (ORR) was assessed by an Independent Review Committee per RECIST v1.1. Per protocol, patients were treated every 6 to 8 weeks for a maximum of 6 cycles. Tumor responses were assessed every 12 weeks (+/- 2 weeks) until disease progression.\nDelcath powered the single arm trial to demonstrate a superior ORR versus checkpoint inhibitors, one of the few mOM treatment categories with a significant amount of peer reviewed publications. The checkpoint inhibitor ORR was calculated based on a meta-analysis covering 16 different publications and 476 patients. Based on those assumptions, a 21.0% ORR was required to demonstrate superiority over the checkpoint inhibitors at a 95% confidence interval. The FOCUS study's intent-to-treat (ITT) population was comprised of a total of 102 mOM subjects. In the ITT population, 91 patients were administered at least one study treatment. Of the 91 patients in the treated population, 51 (56.0%...