Shots:

• The EU approval is based on results of P-III PROSPER trial assessing Xtandi+ ADT vs. PBO + ADT in patients with nmCRPC and PSA level
• The P-III PROSPER trial resulted in mPFS (36.6 vs 14.7mos.). In June- 2013 Xtandi received its first EU approval for mCRPC in men
• Xtandi PO is qd androgen receptor signaling inhibitor targeting ARs- with its availability in 28 EU member including Iceland- Norway and Liechtenstein. It is currently approved in Japan for CRPC and in July- 2018 by FDA as an expanded indication for men with nmCRPC

Ref: Astellas Pharma| Image:Astellas