FDA accepts Delcath liver cancer treatment for standard review
7:19 AM, Oct 15, 2012
NEW YORK -
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.
Delcath has received approval to sell its Chemosat delivery system in Europe.
Shares of Delcath fell 22 cents, or 10.5 percent, to $1.87 in premarket trading Monday. Its shares are up from a 52-week low of $1.40 set in mid-June. They traded as high over the past year as $4.44 in February.