Company intelligence / Profile preview

Delcath Systems

Queensbury, New York, United Statesdelcath.com ↗
Ownership
Public · DCTH
Development stage
Commercial
01

Overview

Delcath’s HEPZATO KIT™ received FDA approval and European marketing authorization for adult patients with unresectable hepatic-dominant metastatic uveal melanoma. The pivotal Phase 3 FOCUS trial demonstrated efficacy in this population. The company has initiated a Phase 2 trial of HEPZATO KIT in combination with standard of care versus standard of care alone in patients with liver-dominant HER2-negative metastatic breast cancer after prior treatment failure. Expanded access programs are available at leading US centers

Therapeutic areas
Oncology
Modalities
DeviceSmall moleculeCombination drug-device product
Industry
Biotech
02

Drug pipeline

2 assets

melphalan

Commercial
Indications
Metastatic uveal melanoma

1 more asset in the full pipeline.

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03

Partnerships

Clinigen Limited (exclusive distribution agreement EEA/UK/international markets)National Cancer Institute CRADACollaborations with leading oncology centers globally

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