The FDA has approved the first blood-based genetic test to detect epidermal growth factor receptor (EGFR) gene mutations present in 10% to 20% of non-small cell lung cancers (NSCLC).
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The test—cobas EGFR Mutation Test v2—is a “companion diagnostic” for patients who may benefit from erlotinib, a treatment for patients with locally advanced or metastatic NSCLC. Insofar as the test provides positive results, the FDA says, it may also benefit patients who are too ill or otherwise unable to provide a tumor specimen for EGFR testing.
The cobas EGFR Mutation Test v2 was evaluated for efficacy in a clinical trial of patients whose tumor biopsies were previously confirmed positive for the EGFR exon 19 deletion or L858R mutations, as determined by the cobas EGFR Mutation Test v1.
Erlotinib is approved for patients with locally advanced or metastatic NSCLC after at least 1 chemotherapy regimen has proved ineffective. It is also approved for first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or L858 substitution mutations as detected by an FDA-approved test. It has not been evaluated as first-line treatment in patients with metastatic NSCLC whose tumors have other EGFR mutations.
