However, it was also designed to specifically target tumor cells with an EGFR mutation known as T790M, which has been shown to cause resistance to the earlier-generation EGFR-targeted therapies. Osimertinib works against tumors with the same EGFR activating mutations (known as exon 19 deletions and exon 21 L858R) targeted by the other EGFR-targeted drugs.
Shortly after those approvals, a series of studies showed that the drugs were effective only in patients whose tumors had specific “activating” mutations in the EGFR gene-that is, mutations that can keep the gene constantly turned on, fueling the cancer’s growth. Gefitinib and erlotinib were the first two EGFR-targeted therapies to be approved by FDA to treat lung cancer. Garrido said during a press briefing on the FLAURA results at the ESMO meeting. But they are present in nearly 40% of patients in some Asian countries, Dr. In European and Caucasian populations, the mutations occur in 10% to 15% of patients with advanced NSCLC. Although EGFR mutations are relatively common in advanced NSCLC, their frequency varies substantially by ethnicity and geographic region, explained Pilar Garrido, M.D., Ph.D., who specializes in treating lung cancer at the Universidad de Alcalá in Spain. Non-small cell lung cancer is the most common type of lung cancer. Improving on the Earlier Generation EGFR-Targeted Drugs The FLAURA results “tell us that is definitely the drug you should be using first” for these patients, Dr. Leora Horn, M.D., clinical director of the Thoracic Oncology Program at Vanderbilt-Ingram Cancer Center in Tennessee, agreed. Ramalingam said, “osimertinib is now the standard of care for first-line therapy.” In patients with advanced NSCLC whose tumors have EGFR mutations, Dr. The finding that osimertinib also improves how long patients live overall further cements its role in treatment, said the FLAURA trial’s lead investigator, Suresh Ramalingam, M.D., of the Winship Cancer Institute of Emory University in Atlanta.
The approval was based on earlier findings from the FLAURA trial showing that the drug improved how long people lived without their cancer getting worse ( progression-free survival).
Osimertinib was approved by the Food and Drug Administration (FDA) in 2018 as an initial, or first-line, treatment for people with advanced NSCLC that has specific EGFR mutations. The trial’s overall survival results were initially presented in late September at the European Society for Medical Oncology (ESMO) annual meeting in Barcelona and were published November 21 in the New England Journal of Medicine. And the survival improvement did not come at the cost of safety the investigators saw no increase in serious side effects in people treated with osimertinib. In the trial, dubbed FLAURA, patients with advanced NSCLC who received osimertinib as an initial treatment lived approximately 7 months longer than patients treated with erlotinib (Tarceva) or gefinitib (Iressa). Updated results from a large clinical trial now show that one of the newest EGFR-targeted drugs, osimertinib (Tagrisso), is more effective than earlier EGFR-targeted therapies in people whose NSCLC tumors have specific alterations in the EGFR gene. The first therapies that target mutated forms of the EGFR protein were approved for use in people with non-small cell lung cancer (NSCLC) more than 15 years ago.