Editor's Choice
Main Category: Cancer / Oncology
Also Included In: Prostate / Prostate Cancer;Â Â Regulatory Affairs / Drug Approvals
Article Date: 28 Apr 2012 - 11:00 PDT
email to a friend  
printer friendly  
opinions  <!-- 
rate article
Patient / Public:
5 (1 votes)
Healthcare Prof:
Amgen's application for expanded indications for denosumab (Xgeva) were turned down by the FDA (Food and Drug Administration) - the expanded indications were to include bone metastases prevention in patients with castration-resistant prostate cancer. The FDA told Amgen in a CRL (Complete Response Letter) that evidence regarding better bone metastasis-free survival was "insufficient", and as such, the potential adverse effects of osteonecrosis of the jaw, among others were not so far compellingly outweighed by the benefits.
Earlier on this year, an FDA Advisory Committee (Oncologic Drugs Advisory Committee) voted that the expanded indication should not go ahead - mainly because of the risk of osteonecrosis.
Osteonecrosis of the jaw or ONJ is when the jaw bone is exposed and suffers from the consequences of not enough blood supply. The bone starts to weaken and dies, which frequently causes severe pain. ONJ is linked to cancer therapies, steroid use, infection, and some other treatments.
Xgeva is already approved for patients with solid tumors, to prevent skeletal-related events, including those with prostate cancer. Patients with multiple myeloma whose malignancy has metastasized are excluded from the current indication.
According to Amgen, Xgeva is the first new bone metastases therapy for patients with advanced cancer in nearly ten years. It is administered every four weeks via subcutaneous injection, in doses of 120 mg.
In a communiqué today, Amgen wrote:
XGEVA is a fully human monoclonal antibody that binds to RANK Ligand, a protein essential for the formation, function and survival of osteoclasts (the cells that break down bone). XGEVA prevents RANK Ligand from activating its receptor, RANK, on the surface of osteoclasts, thereby decreasing bone destruction.
Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, said:
"We are reviewing the complete response letter and will work with FDA to determine any next steps.The FDA's action today does not impact the approved indication of XGEVA in the prevention of skeletal-related events in men with bone metastases from prostate cancer, which was acknowledged by the FDA and the advisory committee members who discussed the application."
Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
- Additional
- References
- Citations
MLA
APA
Please note: If no author information is provided, the source is cited instead.
Add Your Opinion On This Article
'Denosumab (Xgeva) Not Approved For Metastasis Prevention'Please note that we publish your name, but we do not publish your email address. It is only used to let you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.
If you write about specific medications or operations, please do not name health care professionals by name.
All opinions are moderated before being included (to stop spam)
Contact Our News Editors
For any corrections of factual information, or to contact the editors please use our feedback form.
Please send any medical news or health news press releases to:
Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.
Privacy Policy | Terms and Conditions
MediLexicon International Ltd
Bexhill-on-Sea, United Kingdom
MediLexicon International Ltd © 2004-2012 All rights reserved.
Tidak ada komentar:
Posting Komentar