Delcath Systems Inc (DCTH)

[Pikossa]

Crap! Here is the reason. How can this be if it is already approved in Europe? Wouldn't there be enough safety data to prove otherwise?

Delcath’s Chemotherapy Device Has Serious Risks, FDA Staff Says
By Anna Edney - Apr 30, 2013 6:21 AM PT

Delcath Systems Inc. (DCTH)’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 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 19 percent to $1.21 at 8:58 a.m. New York time. The company fell 51 percent in the 12 months through yesterday.
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.
To contact the reporter on this story: Anna Edney in Washington at [e-mail]

http://www.bloomberg.com/news/2013-04-30/delcath-s-chemotherapy-device-has-serious-risks-fda-staff-says.html?cmpid=msnmoney