FDA approves Erleada to treat non-metastatic castration-resistant prostate cancer.- Janssen Pharma.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has approved Erleada (apalutamide), a next-generation androgen receptor inhibitor, for the treatment of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). Erleada is the first FDA-approved treatment for these patients.

This approval follows an FDA Priority Review designation based upon data from the Phase III SPARTAN study, which demonstrated 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 (difference of 24.31 months) in patients with NM-CRPC.

Comment: The need to delay metastasis is critical to the treatment of prostate cancer. Nearly 90 percent of patients with castration-resistant prostate cancer will eventually develop bone metastases, at which point the prognosis sharply worsens.