FDA Approves First Treatment for High-Risk Prostate Cancer

The U.S. Food and Drug Administration (FDA) has approved Erleada (apalutamide) to treat men with prostate cancer that has not yet spread but has a quickly rising PSA level while on treatment with hormone therapy, which causes concern for cancer growth and spread. This is the first FDA-approved treatment for this high-risk type of prostate cancer known as nonmetastatic castration-resistant prostate cancer. Erleada works by blocking the effects of androgens, a type of hormone, on the tumor. Androgens such as testosterone can help tumors grow.

Approval under FDA’s priority review program was based on a randomized clinical trial of 1,207 men with high-risk nonmetastatic castration-resistant prostate cancer that measured the amount of time patients’ tumors did not spread (metastasize). All men in the trial received hormone therapy, but only some also received Erleada. Those who received Erleada had no metastasis for an average 40.5 months compared to 16.2 months for men who did not receive the drug.