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Regulatory News: Article   Printable Version 


Regulatory News Article
Degarelix Approved for Advanced Prostate Cancer

The United States Food and Drug Administration (FDA) has approved Ferring Pharmaceuticals’ agent degarelix for the treatment of advanced, hormone-sensitive prostate cancer. Several trade names for degarelix are currently under review with the FDA; once a chosen trade name is approved, marketing for the agent in its approved indication can begin.

Degarelix is an injectable gonadotropin-releasing hormone (GnRH) receptor antagonist, which binds reversibly to GnRH receptors on pituitary gland cells. Degarelix has demonstrated efficacy against leuprolide (Lupron Depot®) in reducing testosterone to castrate levels or lower, as well as rapidly reducing prostate specific antigen (PSA) levels for at least one year.

Degarelix is Ferring Pharmaceuticals’ first global product launch.



© 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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