ERLEADA™ (apalutamide), a Next-Generation Androgen Receptor Inhibitor, Granted U.S. FDA Approval for the Treatment of Patients with Non-Metastatic Castration-Resistant Prostate Cancer

Today, the US FDA approved Erleada (apalutamide), an androgen receptor inhibitor created by Janssen Pharmaceuticals for the treatment of men with non-metastatic, castration-resistant prostate cancer. Erleada was approved after a priority review of data from the SPARTAN clinical trial. The trial showed a 72 percent reduction in risk of distant metastasis or death, and an increase in median metastasis-free survival (MFS) by more than two years. This offers patients who are non-metastatic and castration-resistant the hope and possibility of delaying metastases.

“As the impact of prostate cancer continues to grow, we are reminded every day of the critical need for therapeutic options that offer patients with prostate cancer more time with their loved ones,” Mark Scholz, MD, Executive Director of the Prostate Cancer Research Institute. “Today’s approval is significant, as it means that patients with non-metastatic castration-resistant prostate cancer now have a treatment option that offers renewed hope.”

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