Pfizer and partner Astellas announced that the FDA has accepted the supplemental New Drug Application looking for label expansion of cancer drug, Xtandi and granted priority review designation.
Xtandi is already approved to treat metastatic and non-metastatic castration-resistant prostate cancer. The label extension Pfizer is hoping for is in men with metastatic hormone-sensitive prostate cancer, meaning the drug will be able to treat a broader prostate cancer patient population.
Xtandi was added to Pfizer’s portfolio with the $14 billion acquisition of Medivation in August 2016. Pfizer sells Xtandi in the United States in partnership with Astellas, while Astellas owns the rights outside the U.S. markets.
Read the press release
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