Wednesday, February 15, 2023
Delcath Systems, Inc., 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).
The 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.
"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."