The US Food and Drug Administration has approved Xofigo (radium Ra 223 dichloride) to treat men with late-stage prostate cancer that has spread to the bone but not to other organs.
The approval is based on a trial that showed men taking Xofigo had an overall survival of 14 months compared to 11.2 months for men taking a placebo (sugar pill).
Xofigo is approved for those men whose cancer has spread despite previous treatment.
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Almost 240,000 men in the US will learn they have prostate cancer, and about 30,000 men will die of the disease this year. About 45,000 men are treated for advanced prostate cancer every year.
Xofigo, manufactured by Bayer, was approved under the FDA priority review program, whereby medication review and approval are expedited. The approval came three months earlier than expected.
This is the first and only so-called “alpha particle-emitting radioactive therapeutic” that not only extends survival, but also delays skeletal events, such as increased pain or fractures.
“Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
Pam Cyrus, MD, head of US Medical Affairs at Bayer, told dailyRx News, "Xofigo is provided by an injection and because it mimics calcium, it really targets the bone."
The safety and efficacy of Xofigo were evaluated in a clinical trial involving 809 men with castration-resistant (does not respond to treatment) prostate cancer that had metastasized to the bone.
"Most men with castration-resistant prostate cancer develop bone metastases, which can decrease overall survival," said Oliver Sartor, MD, North American Principal Investigator for the pivotal trial and medical director of the Tulane Cancer Center.
Initial trial results showed men receiving Xofigo lived a median of 14 months compared to a median of 11.2 months for men who took a placebo.
These results were later updated after finding that men taking Xofigo lived a median of 14.9 months compared to 11.3 months for men on placebo.
Shannon Campbell, vice president & general manager of oncology with Bayer, told dailyRx News that the medication is given by injection over a six-month period. The cost of the entire regimen is $69,000.
Men with private insurance will pay about $150 for the series. Bayer also offers assistance to uninsured and underinsured men, according to Campbell.
The most common adverse reactions experienced by men taking Xofigo included nausea, diarrhea, vomiting and swelling of the legs, feet or ankles. Blood abnormalities were also reported, including low levels of various types of blood cells.
Manufacture of Xofigo is underway, and the drug will be available in about three weeks.
Xofigo is marketed by Wayne, NJ-based Bayer Pharmaceuticals. Xtandi is co-marketed by Astellas Pharma US, Inc. of Northbrook, IL, and Medivation, Inc. of San Francisco, CA.