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

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Ref: Newswire Canada | Image: Janssen