Newswire (Published: Thursday, December 19, 2019, 4:31:00 AM CST, Received: Thursday, December 19, 2019, 5:03:54 AM CST)

Word Count: 193

The FDA has approved Pfizer and Astellas Pharmas Xtandi (enzalutamide) to treat patients with a type of prostate cancer.

The approval allows the treatment to be used on patients with metastatic hormone-sensitive prostate cancer, which is a form of the disease that spreads to other parts of the body. 400,000 men live with this disease in the US.

The drug is the first oral treatment approved by the FDA to be used in treating three different types of advanced prostate cancer.

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

The drug had previously been approved for non-metastatic prostate cancer, a form of cancer which does not spread, and metastatic castration-resistant prostate cancer, which spread and grows despite hormone therapy.

Xtandi has already been prescribed to over 420,000 patients worldwide since it was first approved in 2012.

Prostate cancer is the most common cancer found in men. It is estimated that over 47,000 men are diagnosed with the disease every year, and more than 11,500 die from it every year.

Companies

Pfizer Inc.

Industries

Pharmaceuticals

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Business and Commerce
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            New Products
                  FDA Final Approval
Health and Wellness
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            Men's Health Issues
                  Prostate Cancer
      Medical and Pharmaceutical Regulation
            Drug and Device Approval Process
                  Drug Testing and Approval Process
                        FDA Drug Approval
                  FDA Final Approval
      Treatments and Therapies
            Medicinal Drugs
                  Drug Testing and Approval Process
                        FDA Drug Approval
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                  FDA Final Approval
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