Date: 2015-12-21
Type of information: Development agreement
Compound: companion diagnostic test for glesatinib (MGCD265)
Company: Foundation Medicine (USA - MA) Mirati Therapeutics (USA - CA)
Therapeutic area: Cancer - Oncology
Type agreement: development
Action mechanism: companion diagnostic
Disease: non-small cell lung cancer (NSCLC)
Details: * On December 21, 2015, Foundation Medicine, and Mirati Therapeutics announced that they have entered into a collaboration for the development of a companion diagnostic test for glesatinib. The test, designed for use by physicians, will be used to identify NSCLC patients most likely to respond to Mirati's kinase inhibitor, glesatinib.
The companion diagnostic is part of a coordinated regulatory strategy and is being developed in parallel with the clinical development of glesatinib. The coordinated regulatory strategy is expected to facilitate a submission to the FDA of a Premarket Approval (PMA) for the companion diagnostic, concurrent with the New Drug Application (NDA) for glesatinib. Patients with MET gene amplification and MET mutations are currently being enrolled in a Phase 2 trial of glesatinib. FoundationOne®, Foundation Medicine's comprehensive genomic profiling assay for solid tumors, is being used in the trial to identify those patients most likely to benefit from glesatinib based on patient genomic profiles, which will enable targeted recruitment of patient populations.
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