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Enzalutamide - Astellas Pharma/Medivation

Drug Profile

Enzalutamide - Astellas Pharma/Medivation

Alternative Names: ASP-9785; MDV-3100; Xtandi

Latest Information Update: 26 Mar 2024

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At a glance

  • Originator University of California at Los Angeles; University of Texas M. D. Anderson Cancer Center
  • Developer Alliance for Clinical Trials in Oncology; Astellas Pharma; Bristol-Myers Squibb; Clovis Oncology; M. D. Anderson Cancer Center; Medivation; National Cancer Institute (USA); Pfizer; 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Prostate cancer
  • Phase II Bladder cancer; Breast cancer; Endometrial cancer; Ovarian cancer; Salivary gland cancer
  • Discontinued Liver cancer

Most Recent Events

  • 22 Mar 2024 Astellas anticipates additional license applications for enzalutamide in Prostate cancer and other indication with regulatory authorities in 2024 and beyond
  • 22 Mar 2024 Astellas Pharma anticipates a decision on EU marketing authorisation for enzalutamide in non-metastatic hormone sensitive Prostate cancer by June 2024
  • 22 Mar 2024 CHMP of the EMA adopts a positive opinion recommending approval of enzalutamide as a monotherapy or combination therapy for Prostate cancer (nmHSPC)
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