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Tovorafenib - Biogen/Day One Biopharmaceuticals/Takeda Oncology/Viracta Therapeutics

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Drug Profile

Tovorafenib - Biogen/Day One Biopharmaceuticals/Takeda Oncology/Viracta Therapeutics

Alternative Names: AMG-2112819; BIIB-024; BSK1369; DAY-101; MLN 2480; TAK 580

Latest Information Update: 01 Nov 2023

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At a glance

  • Originator Biogen Idec; Sunesis Pharmaceuticals
  • Developer Biogen; Dana-Farber Cancer Institute; Day One Biopharmaceuticals; DOT Therapeutics-1; National Cancer Institute (USA); Takeda Oncology; Viracta Therapeutics
  • 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

  • Preregistration Glioma
  • Phase II Cholangiocarcinoma; Histiocytosis; Solid tumours
  • No development reported Malignant melanoma

Most Recent Events

  • 30 Oct 2023 US FDA assigns PDUFA action date of 30/04/2024 for Tovorafenib for Glioma
  • 30 Oct 2023 US FDA accepts NDA for Tovorafenib for Glioma for priority review
  • 11 Sep 2023 Day One Biopharmaceuticals anticipates the acceptance of rolling NDA by the US FDA for Glioma (In adolescents, In adults, In children, In infants, Second-line therapy or greater, Monotherapy) by mid November 2023
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