Inside Tulane Med: Quarterly News from the Tulane University School of Medicine

Tulane major player in FDA
approval of new drug for
advanced prostate cancer

Patients fighting late-stage prostate cancer have an important new treatment option for bone tumors thanks in part to a major clinical trial led by Tulane University cancer specialist Dr. Oliver Sartor.

Dr. Oliver Sartor
Dr. Oliver Sartor

The U.S. Food & Drug Administration recently approved radium-223 dichloride, marketed as Xofigo, for the treatment of prostate cancer that has spread to the bones but not other organs. The drug is an alpha particle-emitting radioactive agent that binds to minerals in the bone, delivering radiation directly to tumors while leaving healthy tissue intact. Trial results, which were published this summer in the New England Journal of Medicine, showed that men receiving radium-223 lived more than three months longer than those taking a placebo. The drug was associated with a 30 percent reduction in the risk of death.

"This is an important addition to the treatment of advanced prostate cancer," said Sartor, Tulane Cancer Center medical director and North American principal investigator for the pivotal phase III clinical trial of the drug. "It is immensely satisfying to be part of something that helps move medicine forward and provides new treatments to those who need it most."

Patients from Seattle to Florida were treated at Tulane, which was the leading trial site in North America. Radium-223 was approved more than three months ahead of schedule under the FDA's priority review program, which expedites the review of drugs that appear to provide safe and effective therapy when no satisfactory alternative exists, or offer significant improvement compared to existing treatments.  

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