A closer look at Delcath Systems' refuse-to-file letter

Last week's top story from FierceDrugDelivery discussed the FDA's refuse-to-file letter to New York-based Delcath Systems ($DCTH), which has sought the agency's approval of a liver-cancer treatment that uses catheters to isolate the organ and saturate it with chemotherapy. Just after publishing, I noticed that TheStreet.com's Adam Feuerstein took a deeper look at the agency's concerns regarding how Delcath characterized safety data about the long-approved chemotherapy drug, melphalan, which the firm delivers with its catheter-based system to treat skin cancer that spreads to the liver. "The safety question was the linchpin behind the refuse-to-file letter," Eamonn Hobbs, the company's CEO, told TheStreet. "FDA decided it wanted to see our melphalan safety data stand on its own." Story

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