17 Sep 2013, BioSpectrum Bureau , BioSpectrum
Singapore: The US FDA has rejected Delcath Systems' cancer therapy and asked the company to conduct more clinical trials. A panel of US advisers recommended against the approval of the therapy four months earlier.
The firm has also fired its chief executive Mr Eamonn Hobbs and appointed two interim co-CEOs, including global head of business operations Ms Jennifer Simpson, and chief financial officer, Mr Graham Miao.
The FDA highlighted that additional studies should show that the treatment is safe and effective based on overall survival, and that benefits outweigh risks. Delcath said that the regulator issued a complete response letter, which is 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 that 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.