Amgen seeks FDA OK for additional Xgeva use
THOUSAND OAKS, Calif. (AP) — Biotechnology company Amgen Inc. said Monday it has applied with the Food and Drug Administration to expand the use of its bone treatment Xgeva to prevent or delay the spread of advanced prostate cancer.
The Thousand Oaks, Calif., company said last month it had planned an FDA submission after announcing 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 up to 90 percent of men with advanced prostate cancer will have their tumors spread to the bone.
Xgeva was approved last November to prevent bone fractures in patients with cancer that has spread to the bone. It brought in $42 million in revenue in this year's first quarter, the drug's first full quarter since its launch.
Shares of Amgen climbed 84 cents to close at $57.88 Monday before the application was announced.