Xgeva approved for rare, non-malignant tumor

(HealthDay)—Xgeva (denosumab) has been approved by the U.S. Food and Drug Administration to treat giant cell tumor of the bone (GCTB), a rare tumor that's most often non-cancerous.

The tumor usually affects adults between ages 20 and 40, although it may also develop in adolescents, the FDA said Thursday in a news release. It typically doesn't spread, although in rare cases it can become cancerous and travel to the lungs.

As a non-, GCTB destroys bone as it becomes larger, causing pain, fractures and loss of mobility. Xgeva has been approved in cases where the tumor can't be surgically removed, or might lead to a severe outcome such as loss of a limb, the agency said.

Xgeva, approved under the FDA's expedited review program, was evaluated for this use in two clinical trials involving a total of 305 adults and adolescents. Common side effects included joint pain, headache, nausea, fatigue, back pain and extremity pain.

Women of childbearing potential should use "highly effective" contraception while taking Xgeva, since the drug can harm a fetus, the FDA warned.

The drug was first approved in 2010 to prevent fractures when cancer has spread to the bone. It's marketed by , based in Thousand Oaks, Calif.


Explore further

Simponi approved for ulcerative colitis

More information: The FDA has more about this approval.

Health News Copyright © 2013 HealthDay. All rights reserved.

Citation: Xgeva approved for rare, non-malignant tumor (2013, June 13) retrieved 23 August 2019 from https://medicalxpress.com/news/2013-06-xgeva-rare-non-malignant-tumor.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
 shares

Feedback to editors

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more