Osimertinib Gets Green Light for Advanced NSCLC

The FDA approved osimertinib (Tagrisso; AstraZeneca) for patients with inoperable stage III non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations and whose disease has not progressed following platinum-based chemoradiation therapy. In the placebo-controlled LAURA trial, 216 patients with this form of the disease received either 80 mg of osimertinib once daily or placebo. Median progression-free survival was 39.1 months in the osimertinib arm and 5.6 months in the placebo arm. The incidence of adverse events of grade 3 or higher was 35% in the osimertinib group and 12% in the placebo group.