NDA for Chemosaturation System to Treat Melanoma in the Liver


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Delcath Systems, Inc, announced that it has submitted a New Drug Application (NDA) to the FDA, seeking approval for its chemosaturation system (CHEMOSAT) for use with melphalan hydrochloride in the treatment of patients with unresectable metastatic melanoma in the liver. The system is designed to administer high-dose chemotherapy and other agents to diseased organs or regions of the body, while controlling the systemic exposure of those agents..

In a phase III clinical trial, patients given chemosaturation therapy experienced a statistically significant extension in median hepatic progression-free survival of 5.4 months longer than patients treated with best alternative care (P = .0001, HR = 0.39), according to a blinded intent-to-treat analysis by an independent review committee. Previously reported investigator intent-to-treat analysis of these data showed an extension in hepatic progression-free survival of 6.4 months vs best alternative care (P < .0001, HR = 0.28). ■



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