FDA questions Amgen drug for prostate cancer

By: The Associated Press Email
By: The Associated Press Email

Scientists for the Food and Drug Administration say an Amgen drug slowed the spread of cancer to the bone in men with hard-to-treat prostate cancer, though the drug failed to extend life and carried significant side effects.

The Food and Drug Administration will ask a panel of outside experts on Wednesday whether the benefits of Amgen's Xgeva outweigh its risks, which included bone disease in about 5 percent of patients taking the drug.

Xgeva is already approved for preventing fractures in cancerous bones, and for osteoporosis, in a different formulation called Prolia.

Now Amgen has asked the FDA to approve its injectable drug for men with recurring prostate cancer that is at high risk of spreading to the bone. Men must have also attempted and failed treatment with hormone therapy.


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