Delcath Systems Drug Gets Special FDA Designation

NEW YORK (AP) — Medical-technology company Delcath Systems Inc. said Tuesday the Food and Drug Administration granted its drug candidate melphalan an additional special designation.

The agency gave the company "orphan drug" status for melphalan as a treatment for cancer affecting the body's neuroendocrine system. The in-development drug already has the special designation for two other potential uses in treating cancer. The drug candidate is in midstage development.

Orphan drug status is given to drugs aimed at rare conditions or conditions that have a lack of treatments on the market.

The incentives include seven years of market exclusivity following FDA approval, assistance in clinical trial design, a reduction in user fees, and tax credits.

Shares of New York-based Delcath rose 36 cents, or nearly 10 percent, to $4 in premarket trading.