FDA Grants Frontline Osimertinib Priority Review for NSCLC

December 18, 2017 – The FDA has granted a priority review to a supplemental new drug application (sNDA) for the use of 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 sNDA is based on the phase III FLAURA study, in which frontline osimertinib reduced the risk of progression or death by 54% versus standard TKI … (leggi tutto)