FDA Approves Frontline Osimertinib for NSCLC

April 19, 2018 – The FDA has approved osimertinib as a first-line treatment for patients with non–small cell lung cancer (NSCLC) whose tumors harbor EGFR mutations (exon 19 deletions or exon 21 L858R substitution mutations). The approval is based on the phase III FLAURA study, in which frontline osimertinib reduced the risk of progression or death by 54% versus standard TKI therapy – erlotinib or gefitinib. In the double-blind study, the median progression-free … (leggi tutto)