Pfizer, Astellas clinch expanded approval for Xtandi in earlier line of prostate cancer
Pfizer and Astellas on Thursday nabbed an expanded approval for Xtandi (enzalutamide) to treat non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.
The approval, which came five weeks ahead of its PDUFA date, is based on Phase III results from the companies’ EMBARK trial, which examined Xtandi plus leuprolide, placebo plus leuprolide, and Xtandi on its own in patients with non-metastatic hormone-sensitive prostate cancer with high-risk BCR. The trial enrolled 1,068 patients and met its primary endpoint of a statistically significant reduction in risk of metastasis or death compared to a placebo plus leuprolide.
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