Pfizer Inc. and Astellas Pharma Inc. said the U.S. Food and Drug Administration approved Xtandi to treat a type of prostate cancer.
The regulator approved the companies' supplemental new drug application for Xtandi to treat metastatic castration-sensitive prostate cancer, a type of the disease in which the cancer has spread beyond the prostate and still responds to therapy to lower testosterone levels.
The drug, also known as enzalutamide, was previously approved to treat two other advanced types of the disease: Non-metastatic and metastatic castration-resistant prostate cancer.
The new approval is based on results from a phase 3 study called Arches, in which patients who received both the drug and hormone therapy lived longer without the disease worsening than those who received only the therapy.
New York's Pfizer jointly markets Xtandi in the U.S. with Tokyo-based Astellas, which commercializes the drug elsewhere.