Sky Ridge Medical Center in Colorado, US, has initiated the FDA-approved Delcath Systems' expanded access program (EAP) to provide US patients access to second-generation hemofiltration cartridge of Delcath's proprietary chemosaturation delivery system.
The hemofiltration cartridge, which is currently under active FDA review with a PDUFA goal date of 15 June 2013, is designed to treat patients with unresectable metastatic ocular melanoma in the liver.
Sky Ridge Medical Center interventional radiologist Charles Nutting said patients with unresectable metastatic ocular melanoma often have few choices with regard to treatments.
"We believe the expanded access program provides patients an important access to treatment that could potentially be beneficial," Nutting added.
Delcath Systems president and CEO Eamonn Hobbs said, "As an investigator in our Phase 3 clinical trial, Dr. Nutting has been a pioneer in the development of chemosaturation therapy, and we are pleased that Sky Ridge Medical Center is participating in our EAP under his leadership."