On June 9, 2022, the U.S. Food and Drug Administration (FDA) approved the FoundationOne®CDx as a companion diagnostic for two entrectinib indications:
To identify patients with ROS1-positive non-small cell lung cancer
To identify patients with neurotrophic tyrosine receptor kinase fusion-positive solid tumors.
Both indications are for patients who may be appropriate for treatment with entrectinib.
For more information, read Foundation Medicine's announcement and Roche's announcement.