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Randomized, Double-Blind, Phase 2/3 Study in Subjects With Malignant Pleural Mesotheliomato Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study)

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Trial Profile

Randomized, Double-Blind, Phase 2/3 Study in Subjects With Malignant Pleural Mesotheliomato Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study)

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 16 Jan 2025

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At a glance

  • Drugs Pegargiminase (Primary) ; Cisplatin; Pemetrexed
  • Indications Malignant-mesothelioma
  • Focus Registrational; Therapeutic Use
  • Acronyms ATOMIC-Meso
  • Sponsors Polaris Pharmaceuticals

    • Most Recent Events

    • 10 Dec 2024 According to a Polaris Pharmaceuticals media release, since the successful Phase III trial results in September 2022, the Company has been aligning with FDA guidelines for batch production and six-month continuous activity tests, and aims to obtain its first drug approval for ADI-PEG 20 by 2025, followed by its market launch.
    • 16 Nov 2023 According to a Polaris Pharmaceuticals media release, when the final portion of the BLA is submitted, Polaris Group will actively seek priority review status for this BLA, which, if granted, could expedite the regulatory review process.
    • 16 Nov 2023 According to a Polaris Pharmaceuticals media release, the Company has initiated the rolling submission of its Biologic License Application (BLA) for ADI-PEG 20 to the U.S. Food and Drug Administration (FDA) for the systemic treatment of patients with malignant pleural mesothelioma with non-epithelioid histology, in combination with a platinum agent and pemetrexed. This submission is based on the results of this trial

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