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An Open-Labeled, Singled-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects With Advanced Prostate Carcinoma

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Trial Profile

An Open-Labeled, Singled-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects With Advanced Prostate Carcinoma

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Jun 2022

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At a glance

  • Drugs Leuprorelin (Primary)
  • Indications Carcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Foresee Pharmaceuticals
  • Most Recent Events

    • 31 May 2022 According to a Foresee Pharmaceuticals media release, the EC approval follows the positive opinion granted in March, 2022 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), based on data from this study.
    • 31 May 2022 According to a Foresee Pharmaceuticals media release, the European Commission (EC) has approved the Marketing Authorization Application (MAA) for CAMCEVI 42 mg for the treatment of hormone-dependent advanced prostate cancer and for the treatment of high-risk localized prostate cancer and locally advanced hormone-dependent prostate cancer in combination with radiotherapy. The approval is applicable to all 27 European Union (EU) Member States, Iceland, Norway and Liechtenstein.
    • 26 May 2021 According to a Foresee Pharmaceuticals media release, based on the data from this study the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for CAMCEVI 42 mg, a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate, as a treatment of advanced prostate cancer.
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