They call it now Xofigo

Here's more on this announcement. The Wall Street Journal (5/16, Dooren, Subscript ion Publication) reports that the Food and Drug Administration announced Wednesday that it has approved Bayer AG's metastatic castration-resistant prostate cancer treatment, Xofigo (radium Ra 223 dichloride), three months ahead of schedule under the priority review program. The Journal quotes from the announcement in which CDER Office of Hematology and Oncology Products Director Richard Pazdur, MD, said 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." In August 2012, the agency approved Medivation Inc. and Astellas Pharma's Xtandi (enzalutamide), which reduces testosterone production in men whose metastatic castration-resistant prostate cancer has advanced or reoccurred.         According to the Boston Globe (5/16, Weisman), Bayer AG licensed Xofigo from the Oslo, Norway-based drug manufacturer, Algeta ASA. The two companies will co-market the treatment to "US urologists and oncologists, " but Bayer, which filed the new drug applications with the FDA and with EU regulators, holds "exclusive rights to market" Xofigo outside the US. The drug makers expect that by the end of the year, Xofigo will have been approved in Europe as well.         The AP (5/16) reports that the FDA approval was based in part on a study of "809 men with advanced prostate cancer" in which the men who were randomized to receive "Xofigo typically lived 14 months, compared to 11.2 months" for those in the placebo arm, according to the FDA announcement. Xofigo is an "injectable drug that uses radiation to treat advanced prostate cancer." The FDA approved the treatment "for men whose cancer has grown into bone tumors even after receiving medication or surgery to lower testosterone."         Bloomberg News (5/16, Edney) adds that Xofigo "binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues," Dr. Pazdur explained in the statement. On its Business Updates page, the Boston Globe (5/16, Reidy) notes that according to a press statement Algeta released to announce the approval, Xofigo is the "first alpha particle-emitting radioactive therapeutic agent approved by the FDA."         Also covering the FDA approval are Reuters (5/16, Burger), the Boston Business Journal (5/16, Seiffert, Subscript ion Publication) "BioFlash" blog, HealthDay (5/16, Mundell), Medscape (5/16, Chustecka), MedPage Today (5/16, Gever) and the Renal and Urology News (5/16, Charnow).