16 December 2019 - Xtandi is now FDA approved for the treatment of metastatic castration-sensitive prostate cancer in addition to non-metastatic and metastatic castration-resistant prostate cancer.

Pfizer and Astellas announced today that the U.S. FDA has approved a supplemental new drug application for Xtandi (enzalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). In 2019, it is estimated that just over 40,000 men in the United States are living with mCSPC, a form of prostate cancer that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone.

With this approval, Xtandi is now the first and only oral treatment approved by the FDA in three distinct types of advanced prostate cancer – non-metastatic and metastatic castration-resistant prostate cancer (CRPC) and mCSPC. The approval is based on results from ARCHES, a randomised Phase 3 study which evaluated 1,150 men with mCSPC and met its primary endpoint of radiographic progression-free survival.

Read Pfizer press release