FDA accepts Delcath cancer treatment for review
NEW YORK (AP) — Delcath Systems Inc. says its potential treatment for a form of liver cancer has been accepted by the Food and Drug Administration for a standard review.
The New York company said Monday that regulators aim to complete these reviews within 10 months of a company's submission of a new drug application. Delcath submitted its application on Aug. 15.
Delcath is a specialty drug and medical device company focused on cancer treatments. It makes a system that treats cancer by delivering high doses of a chemotherapy drug directly to the liver while controlling exposure of the rest of the body to the drug.