Janssen Receives EC’s Approval for Expanded Use of Erleada (apalutamide) to Treat Metastatic Hormone-Sensitive Prostate Cancer

Shots:

• The EC’s approval is based on P-III TITAN study assessing Erleada + ADT vs PBO + ADT in 1052 patients in a ratio (1:1) with mHSPC regardless of the extent of disease or prior docetaxel treatment history across 23 countries
• The P-III TITAN study results: improvement in OS with a 33% reduction in risk of death; 52% reduction in rPFS; OS rates after a median follow up of 22.7mos. (82% vs 74%)
• Erleada is an androgen receptor inhibitor, indicated to treat patients with nmCRPC who are at high risk of developing mHSPC in the EU

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