Shots:

• The approval is based on P-III SPARTAN study results assessing Erleada (240 mg-qd) vs PBO in 1-207 patients with NM-CRPC in ratio (2:1) in patients with (NM-CRPC)
• P-III SPARTAN study results: 72% reduction in risk of distant metastasis or death; mPFS (40.51 mos. vs 16.20 mos.); 24% required number of events
• Erleada (apalutamide) is an androgen receptor (AR) inhibitor targeted for patients with NM-CRPC

Ref: Janssen | Image: Janssen