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Regulatory News: Article   Printable Version 


Regulatory News Article

Delcath Receives Orphan Drug Designation for Treatment of Neuroendocrine Tumors

Delcath Systems, Inc. has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for the use of high-dose melphalan in the treatment of neuroendocrine tumors, utilizing their proprietary drug-delivery system. 

The drug-delivery system, Delcath Percutaneous Hepatic Perfusion (PHP) System™, is designed for the direct delivery of high-dose anticancer drugs to the liver. This is Delcath System’s third ODD, which also include high-dose melphalan for the treatment of patients with metastatic cutaneous or ocular melanoma. 

Delcath Systems is currently enrolling patients in Phase II and Phase III clinical trials. 

© 1998-2007 OncoEd.com All Rights Reserved.

These materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. All readers should verify all information and data before administering any drug, therapy or treatment discussed herein. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained herein.
© 1998-2007 OncoEd, Inc  All Rights Reserved.

These materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. All readers should verify all information and data before administering any drug, therapy or treatment discussed herein. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained herein.




   




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