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Defactinib - Verastem Oncology

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Drug Profile

Defactinib - Verastem Oncology

Alternative Names: Defactinib hydrochloride; PF-04554878; PF-4554878; VS-6063

Latest Information Update: 14 Apr 2025

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At a glance

  • Originator Pfizer
  • Developer Cancer Research UK; European Network of Gynaecological Oncological Trial Groups; Gynecologic Oncology Group; National Cancer Institute (USA); Pfizer; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; University of California, San Diego; University of Utah; Verastem; Verastem Oncology
  • Class Amines; Antineoplastics; Benzamides; Fluorinated hydrocarbons; Pyrazines; Pyrimidines; Small molecules; Sulfones
  • Mechanism of Action Focal adhesion protein tyrosine 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; Mesothelioma; Pancreatic cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Ovarian cancer
  • Phase II Gynaecological cancer; Lymphoma; Malignant-mesothelioma; Multiple myeloma; Non-small cell lung cancer; Pancreatic cancer; Solid tumours; Thyroid cancer; Uveal melanoma
  • Phase I/II Fallopian tube cancer; Glioblastoma; Malignant melanoma; Peritoneal cancer
  • No development reported Breast cancer; Cancer

Most Recent Events

  • 20 Mar 2025 FDA assigns PDUFA action date of 30/06/2025 for Defactinib for Ovarian cancer (Combination therapy, Second-line therapy or greater)
  • 31 Dec 2024 US FDA accepts NDA for Defactinib under accelerated approval pathway and grants Priority Review for Ovarian cancer (Combination therapy, Second-line therapy or greater) in USA (PO) (Chugai Pharmaceutical pipeline, February 2025)
  • 06 Nov 2024 Verastem completes rolling NDA submission to the US FDA for combination of avutometinib and defactinib in Ovarian cancer

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