Delcath’s Chemotherapy Device Has Risks, FDA Staff Says

Delcath Systems Inc.’s experimental drug-and-device combination for chemotherapy carries life-threatening risks that may outweigh any benefit, U.S. Food and Drug Administration staff said. The shares fell the most in more than five years .

The Melblez Kit is associated with “a high treatment-related mortality rate that in the best-case scenario would be replicated in the post-marketing setting,” FDA staff said in a report today ahead of a May 2 meeting of agency advisers to discuss the product. The kit is intended to treat eye cancer that can’t be surgically removed and has spread to the liver.

The system performs what New York-based Delcath calls chemosaturation, using the device to inject a high dose of the chemotherapy melphalan to the liver. In clinical studies, eight people, or almost 7 percent, died from adverse reactions including liver failure, hemorrhagic brain lesions and gastrointstinal hemorrhage, FDA staff said. Of the patients who received alternative care, none experienced fatal reactions.

Delcath fell 40 percent to 83 cents at 4 p.m. New York time, the biggest decrease since October 2007. The company has fallen 70 percent in the past year.

Patients who used the Melblez Kit in studies also experienced more serious adverse reactions, including a decreased ability of the bone marrow to make blood cells and liver toxicity, FDA staff said.

The agency extended by three months its decision on whether to approve the kit to Sept. 13 as it looks over information clarifying bridging studies Delcath did to let the company extrapolate data from foreign trials. Delcath generated $350,000 in revenue last year after receiving European approval in April 2011 to sell its Chemosat Delivery System.