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Randomised Phase 3 Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET

Trial Profile

Randomised Phase 3 Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Aug 2019

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At a glance

  • Drugs Enzalutamide (Primary) ; Bicalutamide; Flutamide; Nilutamide
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Therapeutic Use
  • Acronyms ENZAMET
  • Most Recent Events

    • 21 Aug 2019 According to an Astellas Pharma media release, based on the data from ARCHES and ENZAMET trials ,the U.S. Food and Drug Administration (FDA) has accepted for review the filing of a supplemental New Drug Application (sNDA) for XTANDI (enzalutamide) to add an indication for the treatment of men with metastatic hormone-sensitive prostate cancer (mHSPC). The application has been granted Priority Review, designation. The FDA has set a Prescription Drug User Fee Act (PDUFA) date, in Q4 2019.
    • 30 Jul 2019 Primary endpoint has been met. (Overall survival), according to an Astellas Pharma media release.
    • 30 Jul 2019 According to an Astellas Pharma media release, based on the results from this and ARCHES study, the company has submitted a supplemental new drug application for XTANDI ( enzalutamide), to add the indication for the treatment of men with metastatic hormone-sensitive prostate cancer (mHSPC) in Japan.
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