Xtandi Gets Speedy Approval; Medivation/Astellas Already Prepped For Launch

FDA announced approval of Medivation/Astellas’ androgen receptor inhibitor Xtandi (enzalutamide) a little over three months after the NDA for metastatic castration-resistant prostate cancer was submitted, and the sponsors expect to begin promotions shortly after the U.S. Labor Day holiday.

Medivation Inc. and partner Astellas Pharma Inc. are fully prepared for a U.S. launch of Xtandi (enzalutamide) for metastatic castration-resistant prostate cancer despite an approval that came three months ahead of the anticipated action date.

FDA made the announcement the afternoon of Aug. 31, as the U.S. prepared to celebrate the Labor Day long weekend

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