Table 2.

Regulatory agencies (FDA and EC approvals for checkpoint inhibitors in NSCLC (current as of November 15, 2017)

Agent	Disease and biomarker	Single/combination	FDA approval date	EC approval date
Pembrolizumab	Previously untreated metastatic NSCLC (first-line)	Combination with pemetrexed and carboplatin	May 2017	Oct 2017 – Merck withdraws the application
Pembrolizumab	First-line treatment of patients with metastatic NSCLC, with PD-L1 expression (TPS) ≥50% as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations	Single agent	October 2016	January 2017
Atezolizumab	Metastatic NSCLC whose disease progressed during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Atezolizumab	Single agent	October 2016	Sept 2017
Pembrolizumab	Metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) with disease progression on or after platinum-containing chemotherapy	Single agent	October 2015	August 2016
Nivolumab	Metastatic NSCLC with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations	Single agent	October 2015	April 2016
Nivolumab	Metastatic squamous NSCLC with progression on or after platinum-based chemotherapy	Single agent	March 2015	July 2015

Abbreviations: FDA, US Food and Drug Administration; EC, European Commission; NSCLC, non-small cell lung cancer; PD-L1, programmed cell death ligand; EGFR, epidermal growth factor receptor; ALK, anaplastic lymphoma kinase; TPS, tumor proportion score.