Xtandi Gets Speedy Approval; Medivation/Astellas Already Prepped For Launch
This article was originally published in The Pink Sheet Daily
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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New PSA data from the AFFFIRM trial in post-chemo patients indicate prostate cancer drug Xtandi works equally well regardless how advanced the disease, a meaningful finding for heavily pretreated patients like those in the trial. Interim rPFS data from a chemo-naïve study will be available in the second half of 2013, but a supplemental filing most certainly will wait for overall survival results.
Medivation/Astellas’ Xtandi was approved barely a month after FDA announced it had accepted its NDA for post-chemo castration-resistant metastatic prostate cancer, and the newly approved androgen blocker appears to have what it takes to unseat J&J’s market leader Zytiga.