FDA Approves Foundation Medicine Companion Diagnostic for NSCLC

The FDA has approved Foundation Medicine’s FoundationOne Liquid CDx as a companion diagnostic to identify patients with nonsmall-cell lung cancer (NSCLC) whose tumors possess epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitutions who are eligible for treatment with current and future EGFR tyrosine kinase inhibitors.

The companion diagnostic covers Tarceva (erlotinib), Tagrisso (osimertinib) and Iressa (gefitinib), giving oncologists flexibility in choosing the appropriate treatment for their patients.

The approval extends to current and future EGFR tyrosine kinase inhibitors.