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A potentially registrational trial of trial for darovasertib in neoadjuvant UM setting

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A potentially registrational trial of trial for darovasertib in neoadjuvant UM setting

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2024

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At a glance

  • Drugs Darovasertib (Primary)
  • Indications Uveal melanoma
  • Focus Therapeutic Use

    • Most Recent Events

    • 04 Nov 2024 According to an IDEAYA Biosciences media release, Following a successful Type C meeting with the U.S. Food and Drug Administration (FDA), IDEAYA is finalizing the Phase 3 registrational trial protocol and is targeting to initiate its potential registration-enabling trial in the first half of 2025.
    • 23 Sep 2024 According to an IDEAYA Biosciences media release, the company announced successful FDA Type C meeting on registrational trial design for regulatory approval in neoadjuvant Uveal melanoma. Targeting to initiate Phase 3 randomized registrational trial in neoadjuvant UM following finalization of the clinical protocol with FDA.
    • 06 Aug 2024 According to a IDEAYA Biosciences media release, the company plans to conduct a type C meeting with FDA in the third quarter of 2024.

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