The regulator has provided a prescription drug user fee act (PDUFA) date of fourth quarter this year for the review.
The sNDA is being reviewed under two initiatives of the FDA, the Real-Time Oncology Review programme and Project Orbis.
It is based on data from the multi-national, placebo-controlled, randomised, double-blind Phase III EMBARK trial.
A total of 1,068 patients were enrolled from sites in the US, South America, Europe, Canada, and the Asia-Pacific region.
A significant 58% reduction in the risk of metastasis or death was observed in XTANDI plus leuprolide arm compared to placebo plus leuprolide group.
This demonstrates that XTANDI plus leuprolide arm met the primary endpoint of metastasis-free survival (MFS).
Some of the most common adverse events observed in this group included fatigue, hot flush, and arthralgia.
Astellas Oncology Development head and senior vice-president Ahsan Arozullah said: “The addition of XTANDI to leuprolide has shown greater clinical benefit compared to placebo plus leuprolide, and we look forward to working with the FDA and other global regulatory authorities to bring XTANDI to these patients.”
A commercial agreement to jointly develop and commercialise XTANDI in the US was signed between Medivation, a part of Pfizer, and Astellas in October 2009.
If approved, XTANDI is expected to become the first and only hormone therapy to treat this earlier prostate cancer type.