Delcath Systems Inc. (DCTH) failed to win the backing of U.S. advisers for a chemotherapy drug-and-device combination because of the product’s high level of toxicity.
A Food and Drug Administration advisory panel voted 16-0 that the risks of the Melblez Kit outweigh the benefits. 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, almost 7 percent, died from adverse reactions including liver failure, hemorrhagic brain lesions and gastrointestinal bleeding, FDA staff said April 30. Of the patients who received alternative care, none had fatal reactions.
“Patients have very few treatment options,” Mikkael Sekeres, panel chairman and associate professor of medicine staff at the Cleveland Clinic’s Taussig Cancer Institute, said during the meeting today in Silver Spring, Maryland. “Exposing them to a treatment that could kill them in the next month is not the right thing to do. The risks of this treatment far outweigh any benefit and they actually introduce harm.”
The studies the panel considered today were based on an older filter and the company said it plans to use an upgraded filter in use in Europe if the product gains U.S. approval. Delcath didn’t immediately say if it would conduct a new study on the device.
Delcath rose 4.7 percent to 79 cents at 12:55 p.m. before the shares were halted during the meeting. The shares had dropped 74 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 in their report ahead of the advisory panel meeting. Delcath shares tumbled 40 percent on April 30 after release of the report.
The agency extended by three months to Sept. 13 its decision on whether to approve the kit as it looks over information intended to clarify bridging studies on the filter that allow Delcath to extrapolate data from other studies.
Delcath generated $350,000 in revenue last year after receiving European approval in April 2011 to sell its Chemosat Delivery System, which is the device’s name in Europe that was cleared for general use with the liver.
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