In October 2016, based on 2 randomized controlled trials (RCTs), KEYNOTE-010 (7) and KEYNOTE-024 (8), pembrolizumab was approved by the FDA for the treatment of metastatic NSCLC patients identified as PD-L1 positive, that is, with a PD-L1 Tumor Expression Score (TPS) ≥1% as determined by an FDA-approved test. The gene discussed is CD274; the disease is non-small cell lung carcinoma.