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Pfizer: US FDA broadens indication for prostate cancer drug

(CercleFinance.com) - Pfizer's Xtandi drug won approval from U.
S. regulators for patients with non-metastatic castration-resistant prostate cancer, the biopharmaceutical company said on Friday.

The Food and Drug Administration had granted a priority review designation to the drug for this indication, based on positive results from a Phase 3 trial.

The FDA action broadens the indication for Xtandi, making it the first and only oral medication FDA-approved for both non-metastatic and metastatic castration-resistant prostate cancer.

Xtandi was first approved by the FDA in 2012.

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