Delcath Systems Inc. (NASDAQ: DCTH) announced that its CHEMOSAT Hepatic Delivery System for Melphalan has been included as a recommended liver-directed regional therapy option in the newly published ESMO-EURACAN Clinical Practice Guidelines for Uveal Melanoma.

The melphalan percutaneous hepatic perfusion (M-PHP) therapy is listed first among regional treatment options for patients with multifocal liver-only metastases, either as monotherapy or in combination with systemic treatments. The European guidelines cite two Phase 3 trials as supporting data, showing improved hepatic and overall progression-free survival compared with best alternative care.

The ESMO-EURACAN guideline assigns an ESMO-Magnitude of Clinical Benefit Scale score of 3 to M-PHP for patients with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease or limited extrahepatic disease amenable to local therapy.

M-PHP has previously been recognized in the National Comprehensive Cancer Network Clinical Practice Guidelines as a Category 2A recommended treatment option for appropriate patients with hepatic-dominant metastatic uveal melanoma. The therapy has been listed in NCCN guidelines for several years, predating the 2023 FDA approval of HEPZATO KIT.

The company's HEPZATO KIT is approved in the United States for adult patients with metastatic uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and meeting specific criteria for extrahepatic disease. In Europe, the device configuration is approved as a Class III medical device under the trade name CHEMOSAT.

"This inclusion in the ESMO-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.