The FDA announced Wednesday approval of Bayer and Algeta's Xofigo (radium 223 dichloride) to treat men with symptomatic late-stage castration-resistant prostate cancer that has spread to bones but not to other organs. The agency noted that the therapy was reviewed under its priority status programme and has been approved more than three months ahead of the target date of August 14.
The FDA's decision was based on a study of 809 men with symptomatic castration-resistant prostate cancer that spread to bones but not to other organs. In the trial, results showed that men who received Xofigo lived a median of 14 months, versus 11.2 months for men in the placebo arm. The regulator noted that a subsequent exploratory analysis confirmed the ability of Xofigo to extend overall survival.
"Xofigo binds with minerals in the bone to deliver radiation directly to bone tumours, limiting the damage to the surrounding normal tissues," remarked Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. He noted that the therapy "is the second prostate cancer drug approved by the FDA in the past year that demonstrates an ability to extend the survival." In August 2012, the agency cleared Medivation and Astellas' Xtandi (enzalutamide) to treat men with metastatic castration-resistant prostate cancer that has spread to bones but not to other organs.
In 2009, Bayer and Algeta signed an $800-million deal to develop Xofigo, with the companies jointly promoting the drug in the US and sharing profits. Bayer indicated that the commercial production of Xofigo is under way, and first doses are expected to be ready for patient treatment within a few weeks. According to analysts, the therapy may generate sales of $802 million by 2017.
For analysis of the prostate cancer market, see KOL Insight: Prostate Cancer - Competition intensifies in race to the top.
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