Janssen’s Erleada (apalutamide) Receives Health Canada’s Approval for Metastatic Castration-Sensitive Prostate Cancer
Shots:
- The approval is based on P-III TITAN study assessing Erleada (240mg) + ADT vs PBO + ADT in 1052 patients in a ratio (1:1) with mCSPC across 23 countries including North America, Latin America, South America, EU and the Asia Pacific
- The P-III TITAN study resulted in achieving statistical significance in dual 1EPs of OS & rPFS i.e, 33% reduction in risk of death & 52% reduction in rPFS, OS @2yrs. (82% vs 74%)
- Erleada (PO, qd) is an androgen receptor (AR) inhibitor, indicated to treat patients with nmCRPC & mCSPC and has received Health Canada’s approval for nmCRPC on Jul 03, 2018
Click here to read full press release/ article | Ref: Newswire Canada | Image: Reuters