The radium-223 expanded access clinical trial


Just a quick update to information about expanded access to treatment with radium-223 — the injectable form of radiation therapy currently being developed by Bayer Healthcare and Algeta.

Expanded access to radium-223 is now available for the treatment of men with metastatic, castration-resistant prostate cancer (mCRPC) who have previously been treated with docetaxel-based chemotherapy.  About a dozen different centers in the USA are now offering such treatment — at no charge — while this investigational drug is being evaluated for approval by the US Food & Drug Administration. For more details about the expanded access protocol (including the complete list of centers at which expanded access is now being implemented), please just click here.

As previously reported, radium-223 has been shown — in a large, randomized, double-blind, Phase III clinical trial –to extend overall survival of men with chemotherapy-treated patients with mCRPC. The “New “Prostate Cancer InfoLink is expecting that the US FDA will approve this drug for the treatment of this group of men before the end of 2012.

For those who are intestested in these matters, Algeta and Bayer have also publicly announced that the two companies will be co-marketing the drug, and Algeta is currently opening offices in North America to be able to do this.

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