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.
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By offering an early discount and providing clear clinical effectiveness evidence, Astellas Pharma has propelled its prostate cancer drug Xtandi through U.K.’s NICE.
The Food & Drug Administration is approving the first products under the new PDUVA V review process. The Program, as it is known, gives FDA an extra two months with an application in exchange for additional meetings for sponsors. It’s designed to help reduce the number of late-cycle “surprises.” There have been a few hiccups, but so far, it appears to be doing just that.
FDA’s active week included clearing expanded indications for Novartis’s Afinitor Disperz and Janssen’s Nucynta ER.