Approval was based on the clinical trials, ‘LUX-Lung 2’, ‘LUX-Lung 3’, and ‘LUX-Lung 6’, in NSCLC harboring non-resistant EGFR mutations (S768I, L861Q, and/or G719X) and the ‘LUX-Lung 8’ in patients with advanced squamous cell carcinomas of the lung (Table 1). The gene discussed is EGFR; the disease is squamous cell lung carcinoma.