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Another new drug that extends survival time for men with advanced prostate cancer gains FDA approval

Xofigo (radium-223) is the second prostate cancer drug to treat metastatic disease that has come to market during the past year; the first bone-targeted drug to improve survival.

May 15, 2013 -- Today the U.S. Food and Drug Administration (FDA) approved Xofigo for the treatment of men with treatment-resistant prostate cancer whose cancer has spread to bones, but not to other organs. The approval comes almost three months ahead of schedule, according to the FDA.

Xofigo-- formerly known as Alpharadin during clinical development and drug trials--is a first-in-class injectable radiopharmaceutical that was developed jointly by Bayer Healthcare Pharmaceuticals and Algeta, ASA, a Norwegian pharmaceutical company. (Bayer will be marketing Xofigo.) The drug works by delivering radioactive alpha particles directly to prostate cancer cells that have formed tumors in bone. Because the effect of the drug is limited to about a 10-cell radius, toxicity is limited. Experts say Xofigo is the first bone-targeted drug to improve survival in prostate cancer.

During the drug’s progression through clinical trials, the Prostate Cancer Foundation has continuously reported on the encouraging findings that led to FDA approval today. Those findings—from the ALSYMPCA multinational, double-blind, randomized, placebo-controlled Phase III clinical trial that evaluated men with treatment-resistant prostate cancer who were either give best standard medical care and placebo or best standard care and Xofigo—include:

  • Men given Xofigo had an overall survival advantage of about 3 months.
  • Men given Xofigo experienced significantly higher quality of life measures compared to men given placebo.
  • Men given Xofigo experienced a six month longer timeframe to first complications that occurred as a result of their bone tumors—such as fractures or spinal cord compression.
  • Men given Xofigo had a 50% reduction in their risk for spinal cord compression caused by their tumors—a complication that can result in paralysis, severe pain, and other loss of functions.
  • The drug was well tolerated by men in the study.

Read more about Xofigo in Prostate Cancer Foundation’s Advances (see page 3) — Genitourinary Cancers Symposium that we sent out this past March: Triple-Hitter for Alpharadin: Novel Drug Improves Quality-of-Life, Lengthens Time to Cancer-Related Bone Complications and Improves Survival in Men with Advanced Disease.

And learn more in our reporting from last fall’s European Society for Medical Oncology (ESMO) Congress in Vienna—Novel Radiopharmaceutical Shows Survival & Quality of Life Benefit to Men with Metastatic Prostate Cancer-- on promising findings of radium-223, now known as Xofigo. Video of Dr. Chris Parker, a principle investigator on the ALSYMPCA study is included.

PCF is proud to have given seed funding to the early proof of concept of alpha particle technology that paved the way for Xofigo. The work was conducted by Dr. Christopher J. Logothetis at the University of Texas MD Anderson Cancer Center. Funding of this early-high-risk, high-reward work was made possible by the generous contributions of our donors.

Dr. Oliver Sartor, a member of the PCF Research Community, was the principal investigator for the study sites in the United States.

Patients who are interested in finding out where and when newly FDA approved drug Xofigo will be available can call 1-855-696-3446 (1-855-6Xofigo) or visit the website

Read the FDA Press release here:

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