Queensbury, New York, USA, April 6, 2026
ESMO Guideline Inclusion Validates CHEMOSAT Therapy
In a major milestone for interventional oncology and liver-directed cancer therapies, Delcath Systems, Inc. has announced that its CHEMOSAT® Hepatic Delivery System for Melphalan (M-PHP) has been officially included as a recommended treatment option in the ESMO–EURACAN Clinical Practice Guidelines for uveal melanoma. This recognition represents a significant validation of CHEMOSAT as a standard-of-care regional therapy for patients with hepatic-dominant metastatic uveal melanoma (mUM)—a rare and aggressive cancer with limited treatment options.
The updated European guidelines highlight CHEMOSAT under liver-directed regional therapies, emphasizing its role in managing patients with liver-only or liver-dominant metastases, which occur in up to 90% of mUM cases. The inclusion reflects strong clinical evidence demonstrating improved progression-free survival (PFS), overall response rates, and disease control, positioning CHEMOSAT as a critical option in multidisciplinary cancer care pathways.
Strong Clinical Evidence Supports Adoption
The recommendation is supported by data from two Phase 3 clinical trials, which demonstrated significant improvements in hepatic and overall progression-free survival compared to alternative treatments. The ESMO-Magnitude of Clinical Benefit Scale (MCBS) assigned CHEMOSAT a score of 3, indicating meaningful clinical benefit in patients with unresectable liver metastases affecting less than 50% of the liver and limited or no extrahepatic disease. Additionally, CHEMOSAT has long been recognized in the NCCN Clinical Practice Guidelines, where HEPZATO KIT™ (melphalan/HDS) is listed as a Category 2A recommended therapy for appropriate patients with metastatic uveal melanoma.
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As noted in the document on page 1, CHEMOSAT is positioned as a first-listed regional treatment option for patients with multifocal liver-only metastases, either as a standalone therapy or in combination with systemic treatments such as immunotherapy. This dual recognition across major global guidelines underscores the therapy’s robust clinical validation and growing adoption in oncology practice.
Innovative Drug-Device Combination Enhances Targeted Delivery
CHEMOSAT and its U.S. counterpart HEPZATO KIT™ represent a novel drug-device combination approach, enabling high-dose chemotherapy delivery directly to the liver while minimizing systemic toxicity. The system works by isolating hepatic circulation and filtering blood during melphalan infusion, allowing for targeted tumor exposure with reduced side effects. This locoregional treatment strategy is particularly valuable in cancers like uveal melanoma, where metastases are predominantly confined to the liver.
The technology is FDA-approved in the United States and regulated as a Class III medical device in Europe, reflecting its advanced engineering and clinical utility. By delivering higher therapeutic concentrations of melphalan directly to tumor sites, CHEMOSAT has demonstrated the ability to achieve clinically meaningful tumor responses while maintaining a favorable safety profile.
Expanding Role in Multidisciplinary Oncology Care
The inclusion of CHEMOSAT in the ESMO–EURACAN guidelines highlights a broader shift toward multidisciplinary and personalized treatment strategies in oncology. The guidelines recommend integrating liver-directed therapies with systemic treatments, including checkpoint inhibitors and targeted therapies, to optimize patient outcomes. CHEMOSAT is also recognized as a viable option for both HLA-A*02:01-positive and negative patients, expanding its applicability across diverse patient populations.
As emphasized in the image content on page 1, the therapy is now explicitly incorporated into standard treatment algorithms, reinforcing its role in clinical decision-making frameworks. With increasing recognition from global oncology bodies, Delcath is well-positioned to drive further adoption of CHEMOSAT and expand its impact in treating liver-dominant cancers. This development not only strengthens the company’s market position but also represents a meaningful advancement in improving outcomes for patients with metastatic uveal melanoma, a disease with historically limited therapeutic options.
Source: Delcath Systems press release
