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Delcath Systems
Delcath makes the Hepzato Kit, the melphalan percutaneous hepatic perfusion system approved by the FDA in 2023 for uveal melanoma that has spread to the liver, and sells the same device in Europe as Chemosat.
Also called: DelcathDelcath Systems, Inc.melphalan for Injection/Hepatic Delivery System
Overview
Delcath Systems, based in New York, developed percutaneous hepatic perfusion, a procedure that isolates the liver's blood supply to deliver high-dose melphalan directly to liver tumours while filtering the drug from blood returning to the body. Its Hepzato Kit was approved by the FDA in August 2023 for adults with uveal melanoma and unresectable liver metastases, the first approved liver-directed therapy for that disease, and the device is marketed in Europe as Chemosat. Company facts are from the official website and FDA approval records.
Headquarters
New York, NY, US
Scorecard
All companies#263of 1244 companies, score 18
- approved products +6
- modalities +2
- regions +1
- registry trials +9
1 approved, 0 in phase 3, 0 earlier, 0 targets, 20 registry studies. Formula on the scorecards page.
Stage
Public
Website
ApprovedLiver-directed chemotherapy with percutaneous hepatic perfusion
Melphalan hepatic delivery system · Hepzato Kit
High-dose melphalan pumped through the liver's own blood supply while the blood leaving the liver is filtered, the first approved treatment for uveal melanoma that has spread to the liver.
Similar pages
- Key paperEfficacy and Safety of the Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma: Results from an Open-Label, Single-Arm, Multicenter Phase 3 Study
Shares Melphalan hepatic delivery system, FOCUS.
- TrialPHP in Combination With IPI1/NIVO3 Compared to IPI3/NIVO1 Only in Patients With Uveal Melanoma Liver Metastases
Shares FOCUS, Uveal melanoma.
- TechnologyPercutaneous hepatic perfusion (chemosaturation)
Shares An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular Melanoma, FOCUS, Uveal melanoma.
- TreatmentMelphalan (including hepatic delivery system)
Shares An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular Melanoma, Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatme, FOCUS, Uveal melanoma.
cancers
fronts
drugs
ApprovedLiver-directed chemotherapy with percutaneous hepatic perfusion
Melphalan hepatic delivery system · Hepzato Kit