According to a media release issued by Bayer HealthCare, the U. S. Food & Drug Administration (FDA) has given the green light to “fast track” review of the company’s new drug application (NDA) for Alpharadin™ (radium-223 chloride) as a treatment for men with metastatic, castration-resistant prostate cancer (mCRPC).
The FDA’s “fast track” process is intended to ensure the expeditious review of new drugs that may improve the treatment of serious diseases and fill some specific, unmet medical need.
As announced in June this year, radium-223 chloride extended median overall survival by 2.8 months in a large, randomized, Phase III clinical trial. In the ALSYMPCA trial, men on radium-223 had a median overall survival of 14.0 months as compared to 11.2 months for men treated with a placebo. However, the complete results of this trial are still to be presented. Such a presentation is expected at an “upcoming” medical/scientific meeting — but no information has yet been made available regarding which meeting that might be.
There is no information at this time about when an NDA for Alpharadin might be submitted, nor about when Alpharadin might be approved for treatment of mCRPC if the NDA meets FDA criteria for approval. However, it would be reasonable to expect that an NDA might be submitted some time this year, and approval is therefore possible some time in 2012. The “New” Prostate Cancer InfoLink would expect that submission of data to regulatory authorities in Europe (the European Medicines Agency or EMEA) is on a similar timeline.