Amgen: FDA to decide on new Xgeva use by April
THOUSAND OAKS, Calif. (AP) — Biotechnology company Amgen Inc. said Monday that the Food and Drug Administration plans to decide by April 26 on its application to expand the use of its bone treatment drug Xgeva to prevent or delay the spread of advanced prostate cancer.
Amgen has said that Xgeva outperformed a placebo in a late-stage study of how it works in preventing the spread of advanced prostate cancer to bones. A monthly treatment of the injectable drug increased bone metastasis-free survival by about four months on average compared with a placebo.
Amgen said bone is one of the most common places for cancer to spread.
Xgeva was approved last November to prevent bone fractures in patients with cancer that has spread to the bone. An Oppenheimer & Co. analyst has said Xgeva could generate $880 million in sales by 2015 from the expanded use.
Shares of Amgen, which is based in Thousand Oaks, Calif., increased 46 cents, or nearly 1 percent, to $52.44 in morning trading Monday.