Delcath: Safety Questions Behind FDA Delay

Delcath: Safety Questions Behind FDA Delay

NEW YORK (TheStreet) --Questions about the safety of the chemotherapy drug used in Deltcath Systems' liver-tumor treatment system prompted U.S. regulators to issue a rare refuse-to-file letter, Delcath's chief executive said in an interview Tuesday.

The Delcath system is a device that isolates the liver from the body's blood supply, allowing doctors to flood the organ with high doses of the approved chemotherapy drug melphalan. Delcath is seeking approval for the system as a treatment for skin cancer patients who have tumors that spread to the liver.
Delcath CEO Eamonn Hobbs, in an interview, said FDA "didn't like" the manner in which the company characterized the safety of melphalan as used with the company's chemosaturation system.
"The safety question was the linchpin behind the refuse-to-file letter," said Hobbs. "FDA decided it wanted to see our melphalan safety data stand on its own," he added....read more...