The FDA approved pembrolizumab in the first-line setting in this population on 24 October 2016, and on 15 December 2016, the EMA Committee for Medicinal Products for Human Use also approved pembrolizumab as monotherapy in the first-line setting of metastatic NSCLC in adults whose tumors express PD-L1 in a tumor proportion score (TPS) ≥50% and who have no EGFR- or ALK-positive tumor mutations. The gene discussed is ALK; the disease is non-small cell lung carcinoma.