December 17, 2019 / 12:50 AM / a month ago

UPDATE 1-FDA approves expanded label for Pfizer, Astellas' prostate cancer therapy Xtandi

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Dec 16 (Reuters) - The U.S. Food and Drug Administration has approved Pfizer Inc and Astellas Pharma Inc’s Xtandi to treat patients with a type of prostate cancer, the companies said on Monday.

The drug can now also be used to treat patients with metastatic hormone-sensitive prostate cancer, a form of prostate cancer that spreads to other parts of the body.

More than 40,000 men in the United States are living with the disease, according to the companies.

Pfizer said Xtandi, in combination with an anti-hormone therapy, reduced the risk of cancer spreading or deaths by 61% in men with the disease, compared to placebo plus anti-hormone therapy.

The drug is the first and only oral treatment approved by the FDA in three distinct types of advanced prostate cancer, the companies said.

The FDA has earlier approved the drug for non-metastatic prostate cancer, a form of cancer which does not spread to other parts of the body, and metastatic castration-resistant prostate cancer, which spreads and continues to grow despite hormone therapy.

Xtandi has been prescribed to more than 420,000 patients worldwide since it was first approved in 2012, according to the companies. (Reporting by Dania Nadeem in Bengaluru; Editing by Shinjini Ganguli and Subhranshu Sahu)

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