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A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide in Addition to Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

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A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide in Addition to Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

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

Latest Information Update: 27 Nov 2024

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At a glance

  • Drugs Darolutamide (Primary) ; Luteinising hormone modulators
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ARANOTE
  • Sponsors Bayer

    • Most Recent Events

    • 21 Nov 2024 According to a Bayer media release, USFDA has accepted the company's supplemental new drug application (sNDA) for the oral androgen receptor inhibitor (ARi) NUBEQA (darolutamide) in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC), based on the positive results of this trial.
    • 14 Oct 2024 According to an Orion Pharma media release, Orions collaboration partner Bayer today announced the submission of an application to the European Medicines Agency (EMA) for darolutamide. Bayer is seeking approval for the use of darolutamide in combination with androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) based on results from this trial.
    • 26 Sep 2024 According to an Orion media release, the company announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the oral androgen receptor inhibitor (ARi) darolutamide.

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