It received regular FDA approval following data consolidation and publication of the AURA3 study, which showed that osimertinib improved median PFS by 5.7 months (10.1 months vs 4.4 months, hazard ratio: 0.30) over platinum-pemetrexed in EGFR T790M-positive lung cancer patients with disease progression after first-line EGFR-TKI therapy [14]. The gene discussed is EGFR; the disease is lung cancer.