FDA Approves New Treatment Option: Osimertinib Plus Chemotherapy for EGFR+ NSCLC

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The US Food and Drug Administration (FDA) approved a new treatment option for people diagnosed with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.

Prior to this approval, treatment with osimertinib alone was the gold-standard targeted therapy for this population. The recent approval offers another option to patients – the combination of osimertinib with chemotherapy.  

This FDA approval is based on the results of the FLAURA 2 phase III clinical trial, which demonstrated that the addition of chemotherapy to osimertinib extended the time in which the cancer isn’t growing or spreading (median progression-free survival) by about 9 months. The trial enrolled 557 patients in more than 20 countries across the globe. This work is ongoing and will continue to study the benefits of this combination treatment to overall survival for this patient population.  

Learn more information about this FDA approval.