Delcath Systems Treatment Gets Special FDA Status

NEW YORK (AP) — Delcath Systems Inc. said Monday the Food and Drug Administration gave its developing liver cancer treatment doxorubicin orphan drug status.

Orphan drug status is given to drugs aimed at rare conditions or conditions that have a lack of treatments on the market. Incentives include seven years of market exclusivity following FDA approval, assistance in clinical trial design, a reduction in user fees, and tax credits.

Delcath focuses on using drug delivery technology that gives ultra-high doses of anticancer drugs to the liver.

Shares of Delcath rose $1.46, or 48 percent, to $4.50 in premarket trading. The stock has ranged from 82 cents to $4.11 over the past year.