FDA Expands Enzalutamide Approval to Earlier Prostate Cancer
The US Food and Drug Administration (FDA) has approved enzalutamide (Xtandi, Astellas and Pfizer) for men with nonmetastatic castration-sensitive prostate cancer who experience biochemical recurrence and are at high risk for metastasis.
Enzalutamide was previously approved for men with metastatic castration-sensitive prostate cancer. The current approval expands the indication for the drug to an earlier advanced prostate cancer setting.
With this new approval, enzalutamide "becomes the first and only androgen receptor signaling inhibitor approved by the FDA" to treat this earlier prostate cancer patient population, according to a press release from Astellas and Pfizer.