It seems only fitting that Medivation
Timing aside, no one should be shocked that Medivation's Xtandi was approved. The drug, formerly known as MDV3100, looked good in clinical trials in patients that had already received chemotherapy. Patients taking Xtandi lived almost five months longer than those taking placebo.
Gaining FDA approval will allow Medivation and marketing partner Astellas Pharma to sell Xtandi, but the companies will be limited to marketing the drug in the post-chemotherapy setting since those are the patients that were enrolled in the trial used to support its approval.
The big money is in giving metastatic castration-resistant prostate cancer patients an alternative to chemotherapy, as Dendreon's
Xtandi is in a clinical trial in that setting, but it'll be awhile before data proves that the drug extends lives in the pre-chemo setting. Doctors can use it off-label to treat those patients, which might happen if Medivation can get the drug listed in the treatment compendiums, but most of the potential won't be reached until the FDA signs off on the earlier indication and until Medivation and Astellas can market it as a first-line therapy.
Medivation's early approval could be a good omen for Exelixis
Of course, the next blue moon isn't until 2015, so maybe not.
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Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. The Motley Fool owns shares of Johnson & Johnson and Dendreon. Motley Fool newsletter services have recommended buying shares of Johnson & Johnson and Exelixis; and creating a diagonal call position in Johnson & Johnson. The Motley Fool has a disclosure policy.
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