Skip to NavigationSkip to content

FDA approves Pfizer and Astellas Pharma’s prostate cancer drug

Published on 17/12/19 at 10:21am

The FDA has approved Pfizer and Astellas Pharma’s 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.

Conor Kavanagh

Mission Statement
Pharmafile.com is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for Pharmafile.com and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches