FDA approves FoundationOne CDx to guide treatment for non-small cell lung cancer subset
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The FDA approved FoundationOne CDx as a companion diagnostic to guide treatment selection for certain patients with non-small cell lung cancer.
The approval applies to use of FoundationOne CDx (Foundation Medicine) to identify patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R alterations and are appropriate for treatment with FDA-approved EGFR tyrosine kinase inhibitors for this indication.
EGFR mutations are the second most common oncogenic drivers in NSCLC. Exon 19 deletions and substitutions in exon 21 comprise approximately 85% of these mutations, according to a company-issued press release.
“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 the release. “We believe securing a third group companion diagnostic approval for FoundationOne CDx is another critical step toward simplifying the decision-making process for oncologists and their patients by allowing them to uncover all FDA approved treatment options for this indication through one test.”
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