The FDA approval will greatly influence the reach of the drug which was approved for use in advanced prostate cancer patients.
U.S. health regulators approved the use of Medivation Inc's and Astellas Pharma Inc's advanced prostate cancer drug Xtandi in men who have not yet received chemotherapy, the companies said on Wednesday, significantly expanding the potential patient population for the oral medicine.
The expanded Food and Drug Administration approval will also enable the drug to better compete with Johnson & Johnson's Zytiga. The approval triggers $90 million in milestone payments to Medivation by Japan's Astellas under a collaboration agreement.
Xtandi, known chemically as enzalutamide, originally gained U.S. approval in 2012 for use in patients with castration-resistant prostate cancer that has spread beyond the prostate only after they had first received chemotherapy treatment.
"The average duration of treatment should double and the addressable patient population triple in the pre-chemo setting," Sanford Bernstein analyst Geoffrey Porges said in a research note earlier this week.
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