Xtandi Shows Survival Benefit in Prostate Cancer Combo Therapy, But Patent Expiry Looms

Pfizer and Astellas’ Xtandi (enzalutamide) has shown an overall survival (OS) benefit in non-metastatic hormone-sensitive prostate cancer (nmHSPC) patients with high-risk biochemical recurrence (BCR)—but only when used in combination with leuprolide, not as monotherapy. The Phase III EMBARK trial supported Xtandi’s FDA approval in November 2023, followed by a label expansion in Europe in April 2024. While metastasis-free survival (MFS) results were previously significant, the OS benefit in the monotherapy arm lacked statistical significance.

Xtandi is now approved in over 80 countries. However, its patent expiry in Europe (2026) and the US (2027) is expected to cause a steep decline in sales—from $5.59 billion in 2025 to $2.24 billion in 2030, according to GlobalData. This reflects a broader trend, as the industry braces for a major patent cliff, with global patented drug sales projected to fall to just 4% by 2030, down from 12% in 2022.

15-07-2025