FDA Approves New Drug to Fight Advanced Prostate Cancer

Xofigo was fast-tracked for approval and is meant for tumors that have spread to the bones

By EJ Mundell

HealthDay Reporter

WEDNESDAY, May 15 (HealthDay News) -- The U.S. Food and Drug Administration announced Wednesday that it has approved a drug to help men with advanced prostate cancer whose disease has spread to the bones.

The drug, Xofigo, is targeted to patients with late-stage, metastatic disease that has spread to the bones but not to other organs, the FDA said in a news release. It is meant for patients who have already undergone surgery and/or drug therapies such as hormone-based treatments.

The FDA said Xofigo was approved more than three months ahead of the original August 2013 deadline the agency had set for a complete review. Instead, the drug was reviewed under the agency's "priority" review program, designated for medicines that appear safe and effective in a context where no good alternative therapy exists.

"Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, explained in the news release.

In a clinical trial involving more than 800 men with symptomatic prostate cancer that was resistant to hormonal therapy and had spread to the bones, men on Xofigo survived a median of 14 months compared to a little over 11 months for men taking a placebo. Side effects from Xofigo included nausea, diarrhea, vomiting and swelling of the legs and feet. Low levels of red and white blood cells, as well as platelets, were also reported among some patients taking Xofigo, the FDA said.

Pazdur noted that "Xofigo is the second prostate cancer drug approved by the FDA in the past year that demonstrates an ability to extend the survival of men with metastatic prostate cancer." The other drug, Xtandi, was approved by the FDA last August for men with hormone treatment-resistant prostate cancers that have spread or recurred, and who had previously been treated with the drug docetaxel.

According to the American Cancer Society, prostate cancer remains the leading cancer type among men outside of skin cancer, and about one man in every six will develop the illness during his lifetime. Caught early, it is often curable. About 239,000 new cases of prostate cancer are diagnosed among American men each year, and nearly 30,000 men die from the disease annually.

Xofigo is co-marketed in the US by Wayne, N.J.-based Bayer Pharmaceuticals and Algeta US of Cambridge, Mass.

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