Delcath Systems, Inc. has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for the use of high-dose melphalan in the treatment of neuroendocrine tumors, utilizing their proprietary drug-delivery system.

The drug-delivery system, Delcath Percutaneous Hepatic Perfusion (PHP) System™, is designed for the direct delivery of high-dose anticancer drugs to the liver. This is Delcath System’s third ODD, which also include high-dose melphalan for the treatment of patients with metastatic cutaneous or ocular melanoma.
Delcath Systems is currently enrolling patients in Phase II and Phase III clinical trials.