FDA questions new use for Amgen drug

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 review notes that the drug did not increase overall survival, with patients in the drug and placebo groups living about the same amount of time.

Additionally, 5% of patients taking Xgeva experienced the side effect of osteonecrosis of the jaw, in which the bone dies because of poor blood supply.

Although FDA staff members don't openly recommend against the new use for the drug, they quote from an editorial in the Lancet medical journal that said the company's findings on Xgeva "do not support its broad use as a preventive agent for bone metastases in prostate cancer."

International Strategy & Investment analyst Mark Schoenebaum said the FDA's negative review was consistent with analyst expectations.

Even if the FDA ultimately approves the application, Schoenebaum estimates modest U.S. sales of about $300 million. The FDA is expected to make its final decision by late April.

Amgen shares fell 16 cents to $69.12.

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FDA questions new use for Amgen drug