FDA Approves FoundationOne CDx for Entrectinib

On June 9, 2022, the U.S. Food and Drug Administration (FDA) approved the FoundationOne®CDx as a companion diagnostic for two entrectinib indications:

1. To identify patients with ROS1-positive non-small cell lung cancer
2. 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.

Posted 6/9/2022