FDA Approves FoundationOne CDx to Identify EGFR Therapeutics for Certain Patients With NSCLC

The FDA has approved FoundationOne CDx, a next-generation sequencing diagnostic, as a companion diagnostic to identify patients with non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) alternations who are eligible to be treated with EGFR tyrosine kinase inhibitors (TKIs).

The majority (85%) of observed EGFR mutations in NSCLC are deletions in exon 19 and substitutions in exon 21.

“Cancer treatment decision-making is growing more complex as we learn more about the mutations that drive cancers to grow and new treatments become available to target those changes,” Mia Levy, MD, PhD, chief medical officer at Foundation Medicine, said in a statement.

In December 2021, FoundationOne CDx was approved as a companion diagnostic for patients with melanoma undergoing treatment with a BRAF inhibitor. The diagnostic test has also been approved in lung cancer to help identify patients with NSCLC who may be eligible for treatment with capmatinib (Tabrecta), help match patients with NSCLC who may benefit from treatment with alectinib (Alecensa), and identify patients with NSCLC who may be appropriate for treatment with brigatinib (Alunbrig).

FoundationOne CDx is an in vitro diagnostic device that can detect substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements. In addition, the test can identify genomic signatures, including microsatellite instability and tumor mutational burden.

There are a number of EGFR TKIs approved by the FDA, including erlotinib (Tarceva), gefitinib (Iressa), afatinib (Gilotrif), dacomitinib (Vizimpro), and osimertinib (Tagrisso).