FDA Rejects Delcath's Cancer Therapy, Asks for More Trials

September 13, 2013

(Reuters) - Delcath Systems Inc said the U.S. Food and Drug Administration rejected its drug-device cancer therapy, and asked for more trials, more than four months after a panel of U.S. advisers recommended against its approval.

The drug-device combination product consists of a chemotherapy drug, melphalan hydrochloride, and a device known as the Delcath Hepatic Delivery System.

The two are combined in a single package known as the Melblez Kit.

In May, an independent panel of advisers to the FDA unanimously recommended against approval of the therapy, which intends to treat ocular melanoma metastatic to the liver.

In a clinical trial, 7% the 122 patients treated died due to side effects related to the therapy.

Further studies should show that the treatment is safe and effective based on overall survival, and that benefits outweigh risks, the FDA said.

Delcath said the regulator issued on Thursday a complete response letter -- its standard method of telling a company why a drug has not been approved.

Delcath said it was evaluating the rejection letter and would discuss a way forward with the FDA.

The company also said it fired Chief Executive Eamonn Hobbs on September 10 and appointed two interim co-CEOs.


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