FDA fast tracks NDA for Alpharadin in mCRPC

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.

3 Responses

  1. Your wrote that ‘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.’

    Of course even UK-developed drugs are approved later here than in the US. Abiraterone anyone? Not yet … well in the UK anyway …

    Good news though on the fast-tracking …

  2. Dear Jon:

    There was actually a detailed paper published just a few weeks ago comparing the time from submission of data to approval for new cancer drugs approved by the FDA and EMEA. The FDA was clearly better at moving important new cancer therpies through the approval process — by several months. It is also relevant that an EMEA approval in Europe still does not equate to accessibility of the drugs through Europe’s nationalized health systems, which then put in a set of financial barriers to actual use. (Of course these financial barriers are understandable when one considers the potential financial consequences of simply saying “Yes” to open use of any approved drug. Here in the USA we are only just beginning to appreciate those consequences!)

  3. Cheers for the reply and for the link to the paper … though its findings are no surprise!

    We are all too familiar in the UK with the concept that EMEA approval doesn’t necessarily equate to availability in on the NHS. We also need the National Institute of Health & Clinical Excellence (NICE) to tell us if they can afford to provide it on the NHS … and the answer is often “No.”

    Balancing the disparate healthcare requirements of a society is very tough. But it’s galling when NICE says “No” and we then hear about the tens of millions of pounds of debt written off by the NHS for foreign nationals dishonestly receiving NHS care and simply waltzing off without paying their bill.

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