Glesatinib companion diagnostic - Mirati Therapeutics/Foundation Medicine

Drug Profile

Glesatinib companion diagnostic - Mirati Therapeutics/Foundation Medicine

Latest Information Update: 15 Mar 2016

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At a glance

  • Originator Foundation Medicine
  • Developer Foundation Medicine; Mirati Therapeutics
  • Class Diagnostic agents
  • Mechanism of Action Undefined mechanism
  • Orphan Drug Status

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

  • New Molecular Entity No

Highest Development Phases

  • Phase II Non-small cell lung cancer

Most Recent Events

  • 21 Dec 2015 Mirati Therapeutics announces intention to submit PMA to the US FDA concurrent with the NDA filing for glesatinib
  • 21 Dec 2015 Mirati Therapeutics and Foundation Medicine collaborate to develop companion diagnostic for glesatinib in USA for Non-small cell lung cancer
  • 01 Oct 2015 Phase-II clinical trials in Non-small cell lung cancer (Late-stage disease, Metastatic disease, Diagnosis, Second-line therapy or greater) in USA, Australia, South Korea (unspecified route) (NCT02544633; 9192583)
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