Amgen says FDA approves Xgeva as a treatment for rare bone-destroying cancer complication

NEW YORK – Amgen's Xgeva, which is used to treat bone disorders related to cancer, received an additional U.S. marketing approval.

The Food and Drug Administration approved Xgeva as a treatment for hypercalcemia of malignancy, a condition in which a patient's bones break down at an accelerated rate, the company said. It is related to advanced cancer and increases the risk of fractures. It can also lead to kidney failure, mental impairment, coma and death. Amgen said hypercalcemia of malignancy is considered an orphan disease, meaning there are fewer than 200,000 patients in the U.S.

The biotech giant also sells Xgeva for the prevention of skeletal damage from solid tumors, and for inoperable cases of a rare condition called giant cell tumor of bone. The tumors destroy bones, which can cause painful fractures, joint problems, deformity and amputation. The drug is also marketed under the name Prolia as a treatment for osteoporosis.

Combined sales of Xgeva and Prolia grew 31 percent to $573 million in the third quarter.

Shares of Amgen Inc. rose $2.21 to $171.45 in morning trading. Shares of the Thousand Oaks, California, company have climbed 48 percent this year and hit an all-time high of $171.63 early Monday.