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Tovorafenib - Day One Biopharmaceuticals

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Drug Profile

Tovorafenib - Day One Biopharmaceuticals

Alternative Names: AMG-2112819; BIIB 024 - Day One Biopharmaceuticals; BIIB-024; BSK 1369; DAY-101; MLN 2480; OJEMDA; TAK 580

Latest Information Update: 26 May 2025

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At a glance

  • Originator Biogen Idec; Sunesis Pharmaceuticals
  • Developer Day One Biopharmaceuticals; National Cancer Institute (USA); Takeda Oncology
  • Class Amides; Antineoplastics; Pyridines; Pyrimidines; Small molecules; Thiazoles
  • Mechanism of Action Raf kinase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Glioma; Malignant melanoma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Glioma
  • Phase II Craniopharyngioma; Langerhans cell histiocytosis; Solid tumours
  • Discontinued Malignant melanoma

Most Recent Events

  • 13 May 2025 Day One Biopharmaceuticals anticipates decision from the EMA on the MAA for tovorafenib for the treatment of glioma in the European Union by the end of 2025
  • 16 Apr 2025 Preregistration for Glioma (In infants, In children, In adolescents, First-line therapy) in European Union (PO) prior to April
  • 16 Apr 2025 EMA accepts regulatory filing for tovorafenib for Glioma for review

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