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Astellas-Pfizer prostate cancer drug application gets priority review by US FDA

Astellas Pharma Inc. and its U.S. partner Pfizer Inc. secured a priority review designation from the U.S. Food and Drug Administration as they seek additional regulatory approval for their prostate cancer drug Xtandi.

Tokyo-based Astellas and New York-based Pfizer filed a supplemental new drug application for Xtandi for treating men with hormone-sensitive prostate cancer that has spread to other organs. The FDA accepted the application and plans to announce its decision in the fourth quarter.

Xtandi, also known as enzalutamide, is already approved in the U.S., Europe and Japan for the treatment of prostate cancer in patients whose disease does not respond to hormonal treatment.

The pharmaceutical companies' application is backed by results from a phase 3 study, named Arches. It showed that Xtandi combined with androgen-deprivation therapy prolonged the lives of prostate cancer patients without the disease worsening. The application was also supported by a late-stage study named Enzamet. That study showed that patients with prostate cancer treated with Xtandi lived longer compared to other drugs of the same type, although they experienced more side effects.

The companies submitted the results of the two studies to regulators in the EU and Japan to potentially back approval to market Xtandi for metastatic hormone-sensitive prostate cancer.

After lung cancer, prostate cancer is the second-leading cause of cancer death in U.S. men. The American Cancer Society estimates 174,650 new cases of the disease in 2019, with an estimated 31,620 deaths.