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The US Federal Drugs Administration approved the use of Radium 223 (Brand name Xofigo also called Alpharadin) two years ago. The well-known US prostate oncologist Dr Mark Scholz gives an update on the experience of his clinic in using the drug. Click on this link to read his article. Xofigo is not yet available in Australia on the PBS
Paul Edwards posted a topic in New agentsThanks to Chuck Maack for drawing our attention to the report of a recent presentation by Dr Oliver A Sartor who was the principal North American investigator for the clinical trial that led to the approval by the United States Food and Drug Administration (FDA) for radium 223 (brand name Xofigo). In 2013 the FDA approved radium 223 for treatment for patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease. Dr Sartor said that determining whether or not a patient had symptoms of bone metastases could often be a grey area. He considered the extent of bone metastases was more important than the presence of pain in determining whether to treat a patient with radium 223. Dr Sartor was treating patients with metastatic castration-resistant prostate cancer who had a significant burden of bone-metastatic disease, even though they might not be considered symptomatic. After nearly a year of clinical use, Dr Sartor said that the optimal setting for radium 223 appeared to be in combination with new hormonal therapies such as Abiraterone (Xytiga) and Enzalutamide (Xtandi). At present a large multi-country Stage III clinical trial is about to start recruiting in Australia: Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms Dr Sartor said large clinical trials would be needed before radium 223 could be considered for use on patients who did not have metastatic disease or were not castration-resistant.
At its April 2014 meeting the Medical Services Advisory Committee considered an application by Bayer to list Xofigo (radium 223) on the Medicare Benefits Schedule. Xofigo (radium 223) is a new drug which significantly increases life expectancy and quality of life for men with castration-resistant prostate cancer who have bone metastases. The advice to the Health Minister from the Medical Services Advisory Committee has now been made public. The good news is that the Medical Services Advisory Committee has recommended that Xofigo be supported for public funding and listed on the Medicare Benefits Schedule. However, the price for Xofigo recommended by the Medical Services Advisory Committee was not acceptable to Bayer. It's not uncommon for the Government to reject the initial price claimed by a drug company or for a drug company to reject the inital price offered by the Government Bayer is continuing to negotiate the price of the drug with the Government. Bayer said that it "hopes to resolve the outstanding issues...... and to provide Australian patients with access to the drug in a timely manner".