FDA Approves XTANDI — Astellas Pharma US, Inc.

Astellas Pharma US, Inc. received FDA approval for XTANDI (enzalutamide), an oral medication for prostate cancer, which historically generated over $4 billion in annual revenue before its recent patent expiration. The imminent generic availability of enzalutamide creates significant competitive pricing pressure in the androgen receptor pathway market, significantly eroding the blockbuster brand’s market share.