Reuters: Regulatory News: FDA rejects Delcath's cancer therapy, asks for more trials

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FDA rejects Delcath's cancer therapy, asks for more trials Sep 13th 2013, 11:08 Sept 13 | Fri Sep 13, 2013 7:08am EDT Sept 13 (Reuters) - Delcath Systems Inc said the U.S. Food and Drug Administration rejected its cancer therapy, and asked for more trials, more than four months after a panel of U.S. advisers recommended against its approval. The company also said it fired Chief Executive Eamonn Hobbs on Sept. 10 and appointed two interim co-CEOs. 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. Seven percent of the 122 patients treated died due to side effects related to the therapy comprising chemotherapy drug melphalan and a drug delivery device, packaged as the Melblez kit. An independent panel of advisers to the FDA unanimously recommended against approval to the therapy, which intends to treat a rare form of eye cancer that spreads to the liver. Delcath said it was evaluating the rejection letter and would discuss a way forward with the FDA. A transition committee would search for a new CEO and evaluate strategic options, said the company valued at $37.6 million based on its stock's close on the Nasdaq on Thursday. Global head of business operations Jennifer Simpson and Chief Financial Officer Graham Miao would serve as co-CEOs. Link this Share this Digg this Email Reprints

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