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Avutometinib - Verastem Oncology

Drug Profile

Avutometinib - Verastem Oncology

Alternative Names: CH 5127566; CH-5126766; CKI-27; R-7304; RG 7304; RO-5126766; VS-6766

Latest Information Update: 30 May 2024

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At a glance

  • Originator Chugai Pharmaceutical; Thomas Jefferson University
  • Developer Amgen; Chugai Pharmaceutical; Eli Lilly and Company; European Network of Gynaecological Oncological Trial Groups; Gynecologic Oncology Group; Memorial Sloan-Kettering Cancer Center; Roche; Royal Marsden NHS Foundation Trust; Verastem Oncology
  • Class Antineoplastics; Hydrazines; Ketones; Pyridazines; Small molecules
  • Mechanism of Action Mitogen-activated protein kinase inhibitors; Raf kinase inhibitors
  • Orphan Drug Status

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

    Yes - Ovarian cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Ovarian cancer
  • Phase II Gynaecological cancer; Non-small cell lung cancer; Thyroid cancer; Uveal melanoma
  • Phase I/II Colorectal cancer; HER2 negative breast cancer; Malignant melanoma; Pancreatic cancer; Solid tumours
  • No development reported Multiple myeloma

Most Recent Events

  • 24 May 2024 Preregistration for Ovarian cancer (Combination therapy, Recurrent, Second-line therapy or greater) in USA (PO)
  • 24 May 2024 US FDA accepts Verastem’s plan to submit the clinical module to complete the NDA application for avutometinib in Ovarian Cancer, in 2H of 2024
  • 24 May 2024 Verastem anticipates to complete the NDA submission for avutometinib in Ovarian Cancer, in 2H of 2024
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