EGFR and non-small cell lung carcinoma: Based on these findings, OSI received fast-track FDA approval in 2015 for treatment of advanced NSCLC with T790M mutation and was later approved as a front-line agent for newly diagnosed NSCLC harboring activating mutations with or without T790M mutation due to superior efficacy relative to earlier generation EGFR TKIs gefitinib or erlotinib (progression-free survival [PFS] 18.9 versus 10.2 months) (18).