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Melphalan drug delivery system - Delcath Systems

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Drug Profile

Melphalan drug delivery system - Delcath Systems

Alternative Names: CHEMOSAT; CHEMOSAT® Hepatic Delivery System for Melphalan; CS-PHP-Melphalan; Generation Two CHEMOSAT Delivery System for Melphalan; Hepzato Kit; HEPZATO-KIT; Melblez Kit; melphalan hydrochloride for injection/hepatic delivery system; Melphalan/HDS; Melphalan/Hepatic Delivery System

Latest Information Update: 06 Feb 2024

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At a glance

  • Originator Yale University School of Medicine
  • Developer Delcath Systems; Leiden University Medical Center
  • Class Antineoplastics; Aromatic amino acids; Myeloablative agonists; Nitrogen mustard compounds; Small molecules
  • Mechanism of Action Alkylating agents; DNA damage stimulants; Immunosuppressants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Liver cancer; Neuroendocrine tumours; Malignant melanoma; Uveal melanoma; Cholangiocarcinoma; Multiple myeloma
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Liver metastases
  • Phase II/III Cholangiocarcinoma
  • Phase II Liver cancer

Most Recent Events

  • 06 Feb 2024 The Centers for Medicare and Medicaid Services (CMS) issues a permanent and product-specific J-code (J9248) for HEPZATO, effective from April 1, 2024
  • 16 Jan 2024 Launched for Liver metastases (In adults) in USA (Intrahepatic)
  • 01 Sep 2023 Delcath Systems plans to launch melphalan drug delivery system for Liver metastases arising from Uveal melanoma (Metastatic disease) in USA (Intrahepatic, infusion) by the end of 2023
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