Monthly Archives: February 2012

Associated Press February 6, 2012, 3:55 p.m. Washington— Scientists for the Food and Drug Administration say that an Amgen Inc. drug slowed the spread of cancer to the bone in men with hard-to-treat prostate cancer, though the drug did not extend life and carried significant side effects. The Food and Drug Administration will ask a panel of outside experts Wednesday whether the benefits of Amgen's Xgeva outweigh its risks, which included bone disease in about 5% 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 the injectable drug as a preventive measure 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. A 1,432-patient study conducted by the Thousand Oaks company showed that the drug slowed the spread of cancer to the bone by about 4.2 months compared with patients who received a placebo. Although that delay was statistically significant, the FDA's reviewers questioned whether it was "an adequate measure of clinical benefit" for patients with prostate cancer. The FDA's … Continue reading →

An Amgen drug slowed the spread of cancer to the bone in men with hard-to-treat prostate cancer, though the drug did not extend life and carried significant side effects, scientists for the Food and Drug Administration say. 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. The agency posted its review of the drug online Monday morning ahead of the meeting. 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 the injectable drug as a preventive measure 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. A 1,432-patient study conducted by Amgen showed the drug slowed the spread of cancer to the bone by about 4.2 months when compared to patients who received placebo. While that delay was statistically significant, the FDA's reviewers questioned whether it is "an adequate measure of clinical benefit" for patients with prostate … Continue reading →