ERLEADA® for Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Among all registration trials in mCSPC:
ERLEADA® is the FIRST AND ONLY AR inhibitor to achieve a 35% reduction in the risk of death vs ADT alone
(ERLEADA® + ADT vs placebo + ADT; median OS: NR vs 52.2 months; HR=0.65; 95% CI: 0.53, 0.79; P<0.0001)*1
*TITAN final analysis data are not currently reported in the ERLEADA® Prescribing Information. The following TITAN primary analysis results are included in the ERLEADA® Prescribing Information: Median OS: NE vs NE; HR=0.67; 95% CI: 0.51, 0.89; P=0.0053.2
ADT = androgen deprivation therapy; AR = androgen receptor; CI = confidence interval; FDA = US Food and Drug Administration; HR = hazard ratio; mCSPC = metastatic castration-sensitive prostate cancer; NR = not reached; OS = overall survival; TITAN = Targeted Investigational Treatment Analysis of Novel Antiandrogen.
1. Chi KN, Chowdhury S, Bjartell A, et al. Apalutamide in patients with metastatic castration-sensitive prostate cancer: final survival analysis of the randomized, double-blind, phase III TITAN study [published online April 29, 2021]. J Clin Oncol. doi.org/10.1200/JCO.20.03488
2. ERLEADA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.