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news.Delcath Systems, a development stage, specialty pharmaceutical and medical device company focused on oncology, has filed the left out modules of its 505(b) (2) new drug application (NDA) to the US Food & Drug Administration (FDA) for Chemosaturation delivery system.
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Delcath Systems is seeking an indication for the percutaneous intra-arterial administration of melphalan hydrochloride for use in the treatment of patients with metastatic melanoma in the liver.
Delcath Systems has requested priority review of the NDA by the FDA, which if granted could result in a 6-month review of the application.
Delcath Systems president and CEO Eamonn Hobbs said they believe that their application is comprehensive and complete, and they are optimistic that it will be accepted for review by the FDA.
"Considering the limitations of current treatment options, we believe the chemosaturation system can offer hope to patients with metastatic melanoma in the liver," Hobbs said.
"With the strength of our Phase III data, we believe that our application meets the FDA’s criteria for priority review."