Pembrolizumab was approved by the FDA on 2 October 2015 for metastatic NSCLC patients who progressed after platinum-based therapy or EGFR- or ALK-targeted therapy and are positive for PDL-1, via accelerated approval based on the randomized, open-labeled, phase II/III study, Keynote-010 trial, showing improved ORR, PFS, and OS compared to Docetaxel in tumors with at least 1% expression of PDL-1 [50]. The gene discussed is EGFR; the disease is non-small cell lung carcinoma.