http://pharmaweblog.com/blog/2007/04/01/dawn-active-immunotherapy/ Pharmaceutical and biotech science and business Fri, 29 Aug 2008 23:40:56 +0000 http://wordpress.org/?v=2.0.2 http://pharmaweblog.com/blog/2007/04/01/dawn-active-immunotherapy/#comment-57 Wed, 09 May 2007 20:55:25 +0000 http://pharmaweblog.com/blog/2007/04/01/dawn-active-immunotherapy/#comment-57 [...] Early in April, I wrote a blog piece highlighting Dendreon’s emerging active immunotherapy for prostate cancer, branded as Provenge.  I was bullish on the prospects for this form of therapy and suggested that the FDA was likely to approve the drug after its first BLA review cycle.  Well, that didn’t happen.  Today, Dendreon told the public that CBER granted a complete response to its BLA for Provenge.  Complete response letters for BLAs are essentially the equivalent of approvable letters for NDAs.  Dendreon did not provide details on the CR letter, except to note that FDA requested further information related to efficacy and CMC issues.  [...] […] Early in April, I wrote a blog piece highlighting Dendreon’s emerging active immunotherapy for prostate cancer, branded as Provenge.  I was bullish on the prospects for this form of therapy and suggested that the FDA was likely to approve the drug after its first BLA review cycle.  Well, that didn’t happen.  Today, Dendreon told the public that CBER granted a complete response to its BLA for Provenge.  Complete response letters for BLAs are essentially the equivalent of approvable letters for NDAs.  Dendreon did not provide details on the CR letter, except to note that FDA requested further information related to efficacy and CMC issues.  […]

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