Enzalutamide - Astellas Pharma/Medivation

Drug Profile

Enzalutamide - Astellas Pharma/Medivation

Alternative Names: ASP 9785; MDV 3100; Xtandi

Latest Information Update: 23 Mar 2018

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At a glance

  • Originator University of California at Los Angeles; University of Texas M. D. Anderson Cancer Center
  • Developer Astellas Pharma; Bristol-Myers Squibb; Clovis Oncology; H. Lee Moffitt Cancer Center and Research Institute; M. D. Anderson Cancer Center; Medivation; National Cancer Institute (USA); Queen Mary University of London; The Prostate Cancer Clinical Trials Consortium; University of California, Davis; University of Chicago; University of Rochester
  • Class Antineoplastics; Benzamides; Fluorobenzenes; Imidazolidines; Nitriles; Small molecules; Thiones
  • Mechanism of Action Androgen receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Prostate cancer
  • Phase II Bladder cancer; Endometrial cancer; Salivary gland cancer
  • Phase I Pancreatic cancer
  • Discontinued Breast cancer; Hepatocellular carcinoma

Most Recent Events

  • 19 Mar 2018 The US FDA sets PDUFA date of July 2018 for sNDA review for Prostate cancer (Hormone-refractory, non-metastatic disease)
  • 19 Mar 2018 US FDA accepts sNDA for enzalutamide for Prostate cancer (Hormone-refractory, Non-metastatic disease) for review
  • 16 Mar 2018 European Medicines Agency (EMA) accepts Type II Variation for enzalutamide for Prostate cancer (Hormone-refractory, Non-metastatic disease) for review
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