NEW YORK – Foundation Medicine said Tuesday that it has expanded an ongoing collaboration with Bristol Myers Squibb to include companion diagnostic development for the pharma firm's investigational tyrosine kinase inhibitor repotrectinib.
Repotrectinib is an orally administered tyrosine kinase inhibitor that is being evaluated in an ongoing registrational Phase I/II trial called TRIDENT-1 for patients with TKI-naive or TKI-pretreated ROS1+ advanced non-small cell lung cancer, as well as those with NTRK+ advanced solid tumors.
BMS has been using the FoundationOne CDx tissue-based genomic profiling assay to recruit these biomarker-defined patients. If the drug is ultimately approved by the US Food and Drug Administration, Foundation's CDx assay could also be approved as a companion diagnostic.
Jason Adams, Foundation's VP of biopharma enterprise partnerships, said in a statement that the move furthers the company's commitment "to deliver more treatment options to patients who need them."
FoundationOne CDx is already FDA approved for genomic profiling in advanced cancer, and as a companion diagnostic for a number of FDA-approved drugs including those targeting alterations in EGFR, ALK, BRAF, and MET.