FDA Grants Accelerated Approval for Elrexfio (elranatamab-bcmm) for Relapsed or Refractory Multiple Myeloma
August 14, 2023FDA Approves First Therapeutic Indication for Revance’s Daxxify (daxibotulinumtoxinA-lanm) for Injection for the Treatment of Cervical Dystonia
August 14, 2023Aug. 14, 2023 - Delcath Systems, Inc., has announced that the US Food and Drug Administration (FDA) approved Hepzato Kit (melphalan/Hepatic Delivery System) as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.
mUM is a rare and aggressive form of metastatic cancer with a U.S. incidence of approximately 1,000 cases per year. Ninety percent of mUM involves the liver, and liver failure is often the cause of death. National Comprehensive Cancer Network (NCCN) guidelines recommend liver-directed therapies for mUM patients with liver metastases. Hepzato Kit is the only liver-directed therapy approved by the FDA for the treatment of mUM and percutaneous hepatic perfusion (PHP), the procedure enabled by Hepzato Kit, is already included in the NCCN guidelines.
Hepzato Kit is a combination product that administers HEPZATO (melphalan), a well-known and long- approved chemotherapeutic agent, directly to the liver through Delcath's novel device delivery system, the Hepatic Delivery System (HDS), which permits higher drug exposure in target tissues while limiting systemic toxicity. The use of the HDS allows a healthcare provider team to surgically isolate the liver while the hepatic venous blood is filtered during melphalan infusion and subsequent washout during a Percutaneous Hepatic Perfusion (PHP) procedure.