Astellas’ Xtandi (enzalutamide) Receives EU’s Approval for Men with High-Risk Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)

 Astellas’ Xtandi (enzalutamide) Receives EU’s Approval for Men with High-Risk Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)

Astellas’ Xtandi (enzalutamide) Receives EU’s Approval for Men with High-Risk Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)

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

Click here to read full press release/ article | Ref: Astellas Pharma| Image: Netherlands Foreign Investment Agency

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

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