Delcath files new FDA application for chemo drug-device combination
Delcath files its 2nd new drug application in hopes of gaining FDA approval for the ChemoSat Generation 2 chemotherapy isolation system.
Delcath Systems (NSDQ:DCTH) filed a new FDA application for the latest iteration of its ChemoSat drug-device combination, the Generation 2 device, in treatment of patients with non-operable liver cancer.
Delcath's ChemoSat uses a system of tubes to localize the delivery of toxic chemotherapy agents by isolating the targeted organ — in this case, the liver — from the rest of the body's bloodstream.
Delcath must seek new drug approval for the melphalan hydrochloride the ChemoSat system uses to destroy cancerous tissue.