Delcath Wins Orphan Drug Designation For Doxorubicin

Delcath Systems has reported that the FDA has granted orphan drug designation for doxorubicin for the treatment of hepatocellular carcinoma (HCC).

Doxorubicin is a common chemotherapy agent shown to be effective for the treatment of HCC, as well as hematological malignancies, soft tissue sarcomas, and many types of carcinoma.

Delcath Systems’ early clinical studies of doxorubicin with its Percutaneous Hepatic Perfusion (PHP) technology, allows physicians to deliver significantly higher doses of anti-cancer drugs to the liver without exposing the patient’s entire body to same potent levels of drug.

Moreover, the company plans to perform the clinical work necessary for a submission to the FDA of PHP with doxorubicin for treatment of HCC.

Eamonn Hobbs, president and CEO of Delcath, said: Doxorubicin has an established track record as a treatment for several cancers, including HCC. We believe that Delcath’s Percutaneous Hepatic Perfusion System can deliver high-dose doxorubicin to the liver and spare the patient from systemic exposure, thereby creating a new, tolerable and effective treatment option for these patients. It is our plan to aggressively pursue this indication with the required clinical work.