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news.The US Food and Drug Administration (FDA) has granted fast track status for Algeta's radium-223 chloride to treat castration-resistant (hormone refractory) prostate cancer in patients suffering from bone metastases.
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Earlier in September 2009, Bayer has entered into a pact with Algeta to develop and commercialize radium-223 chloride.
A Phase III trial conducted by Algeta and Bayer Pharma investigating radium-233 chloride for treating symptomatic bone metastases in CRPC patients met primary endpoint by improving overall survival.
Algeta president and CEO Andrew Kay said the positive results at the pre-planned interim analysis of the pivotal phase III study was an achievement for Algeta and for Bayer, reinforcing the common belief of radium-223 chloride’s potential to become an important treatment for bone metastases initially with prostate cancer.
"We are pleased that it has now been granted Fast Track designation by the FDA, as this represents an important step towards the filing which we anticipate in mid 2012 ahead of previous expectations," Kay said.