FDA to prolong decision for Amgen’s Xgeva until April
THOUSAND OAKS, Calif. (AP) —Amgen declared that the US regulatory agency is expected to decide by April 26 regarding the company’s application to expand the use of Xgeva. The company intends to use the bone treatment drug to limit or impede the proliferation of advanced prostate cancer.
The injectable drug Xgeva proved its superiority to placebo in a late-stage clinical trial by inhibiting the spread of advanced prostate cancer to bones, said Amgen. Compared to placebo, a one-month treatment Xgeva prevented bone metastasis and prolonged survival by 4 months, on average.
Thousand Oaks, Calif based Amgen said cancer often spreads to the bone. Xgeva received FDA approval last November to prevent bone fractures in cancer patients with bone metastases. Through its expanded use, Xgeva has the potential to churn out $880 million worth sales profits by 2015, said an Oppenheimer & Co. analyst.
In Monday morning trading, Amgen shares jumped 46 cents, or nearly 1 percent, to $52.44.