FDA Approves EGFR-Mutation Test for Use With Gefitinib in NSCLC
Posted: Thursday, August 30, 2018
The U.S. Food and Drug Administration (FDA) recently approved the cobas EGFR Mutation Test v2 as a companion diagnostic test with gefitinib (Iressa) for the first-line treatment of patients with non–small cell lung cancer (NSCLC). A companion diagnostic test provides information that is essential for the safe and effective use of a corresponding therapeutic product. Clinical studies have demonstrated that patients diagnosed with NSCLC who test positive for defined mutations of the EGFR gene benefit from tyrosine kinase inhibitor therapies.
The cobas EGFR Mutation Test v2 is currently the only FDA-approved diagnostic test for NSCLC using liquid biopsy. EGFR testing in plasma offers a noninvasive option for patients, using a blood draw for those who are not eligible for a tissue biopsy.
The cobas EGFR Mutation Test v2 is a real-time polymerase chain reaction test for the qualitative detection of 42 defined mutations of the EGFR gene in exons 18 to 21, including L858R, exon 19 deletions, and T790M mutations. A number of published clinical studies, such as AURA, AURA2, FLAURA, ENSURE, EURTAC, and FASTACT2, have demonstrated that this test detects defined mutations of the EGFR gene from a tumor tissue biopsy or from plasma and is able to identify those patients most likely to respond to EGFR tyrosine kinase inhibitors.
