Amgen: Xgeva panel review scheduled for February
THOUSAND OAKS, Calif. (AP) - Amgen Inc. said Thursday that it will meet with a Food and Drug Administration panel in February to discuss a possible new approval for its bone drug Xgeva.
On Feb. 8, Amgen will meet with the advisory panel to discuss Xgeva's use in preventing advanced prostate cancer from spreading to the bones of patients. Amgen filed for the new marketing approval June 27, and the FDA is scheduled to make a decision by April 26.
The FDA approved Xgeva in November 2010 for the prevention of bone fractures in patients with cancer that has spread to the bone. The drug is also marketed under the name Prolia as a treatment for osteoporosis in postmenopausal women. Prolia was approved in June 2010.
Shares of Amgen rose 74 cents to close Thursday at $64.74.