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Delcath Systems (DV3R) Drug Pipeline

Drug pipeline
Drug NameConditionStageStatusStudy NameTrial Start DateArticle
Melphalan/Hds Followed By Physician's Choice Of Soc, Physician's Choice Of SocMetastatic Breast Cancer In The LiverPhase IIRecruitingEvaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Breast Cancer w/Liver Dominant DiseaseMar 06, 2025
Melphalan/Hds Followed By Consolidation Treatment With Trifluridine-Tipiracil Plus Bevacizumab, Trifluridine-Tipiracil Plus Bevacizumab AloneRefractory Metastatic Colorectal CancerPhase IIRecruitingEvaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant DiseaseSep 14, 2024
Melphalan With Hepatic Delivery System, HepzatoMetastatic Uveal Melanoma, Metastatic Ocular MelanomaPhase IIIUnknownAn Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular MelanomaAug 18, 2021―
Melphalan/HdsUveal Melanoma, Ocular MelanomaPhase IIICompletedPercutaneous Hepatic Perfusion in Patients With Hepatic-dominant Ocular MelanomaFeb 01, 2016―

FAQ

What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Delcath Systems, Inc. (DE:DV3R) have in its pipeline
Delcath Systems DE:DV3R is currently developing the following drugs: Melphalan/Hds Followed By Physician's Choice Of Soc, Physician's Choice Of Soc, Melphalan/Hds Followed By Consolidation Treatment With Trifluridine-Tipiracil Plus Bevacizumab, Trifluridine-Tipiracil Plus Bevacizumab Alone, Melphalan With Hepatic Delivery System, Hepzato, Melphalan/Hds. These drug candidates are in various stages of clinical development as the company works toward FDA approval.