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FDA rejects Delcath's cancer therapy, asks for more trials
September 13, 2013 / 11:11 AM / 4 years ago

FDA rejects Delcath's cancer therapy, asks for more trials

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.

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