On April 6, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on liver-directed cancer therapies, reported that its proprietary CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (M-PHP) has been included as a recommended liver-directed regional therapy option in the newly published Uveal Melanoma: ESMO (Free ESMO Whitepaper)–EURACAN Clinical Practice Guideline for diagnosis, treatment and follow-up (April 2026).
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M-PHP is also recognized in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Metastatic Uveal Melanoma. HEPZATO KIT (also referred to as melphalan/HDS), is included as a Category 2A recommended treatment option for appropriate patients with hepatic-dominant metastatic uveal melanoma (mUM). M-PHP has been listed as a liver-directed therapy option in NCCN guidelines for several years, predating the 2023 FDA approval of HEPZATO KIT.
The ESMO (Free ESMO Whitepaper)-EURACAN guideline recognizes M-PHP under regional treatments for patients with liver-dominant mUM. Two Phase 3 trials of M-PHP (NCT02678572 and NCT00324727) are cited as key supporting data, demonstrating improved hepatic and overall progression-free survival, and overall response rates compared with best alternative care. The guideline also assigns an ESMO (Free ESMO Whitepaper)-Magnitude of Clinical Benefit Scale score of 3 to M-PHP in the supplementary materials, for patients with unresectable hepatic metastases affecting <50% of the liver and no extrahepatic disease or limited extrahepatic disease amenable to local therapy.
M-PHP is listed first among regional treatment options for patients with multifocal liver-only metastases, either as monotherapy or in combination with systemic treatments, based on HLA-A*02:01 status. In addition, the guideline notes that the M-PHP may be an option in HLA-A*02:01-positive cases (e.g., following tebentafusp or when systemic options are not suitable), as well as HLA-A*02:01-negative cases or those not candidates for other systemic therapies. The ESMO (Free ESMO Whitepaper)–EURACAN guidelines emphasize a multidisciplinary approach for mUM and position liver-directed therapies such as M-PHP alongside systemic options including tebentafusp and anti-PD-1 immunotherapy in the treatment algorithm for metastatic disease.
"This inclusion in the ESMO (Free ESMO Whitepaper)–EURACAN guidelines represents an important validation of PHP with melphalan as a meaningful liver-directed therapy for patients with mUM," said Gerard Michel, Chief Executive Officer of Delcath Systems. "With up to 90% of mUM patients developing liver metastases, and limited effective options available, the recognition of our therapy in the European guidelines further supports its role in multidisciplinary care and highlights the clinical benefit observed in the FOCUS trial and real-world experience. We are pleased that the CHEMOSAT platform is now explicitly addressed in this updated standard of care."
(Press release, Delcath Systems, APR 6, 2026, View Source [SID1234664181])