OBJECTIVES: 1) To identify products indicated for treatment of non-small-cell lung carcinoma (NSCLC) approved with a PRO labeling claim in Europe and the US; and (2) to list the differences found in Europe versus the US in terms of products and labeling. METHODS: The search was performed on the Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved medicinal product labels and on the FDA medical reviews and EMA scientific discussions. RESULTS: A total of 15 products (generics excluded) were identified, six at the EMA and nine at the FDA. The six products approved by the EMA were also approved by the FDA. Four products with a PRO claim were identified in Europe (i.e., docetaxel, erlotinib, gefitinib and paclitaxel), and two in the US (i.e., paclitaxel and gemcitabine). Most of the PROs identified in the claims were quality of life and symptoms. For four products (i.e., docetaxel, erlotinib, gefitinib and paclitaxel), the EMA and FDA showed disagreement in terms of PRO labeling. The EMA gave a PRO claim (quality of life and symptom) to three products, but not the FDA; for paclitaxel, the FDA did not include quality of life in the label. Except for gefitinib, the reviews of both agencies were conducted on the same clinical studies. The analysis of the medical reviews and scientific discussions showed that FDA did not include the PROs in the label because of concerns about the quality of the study design, of the analyses, or the questionnaires’ content validity. CONCLUSIONS: Our review showed that the patients’ perspective in the treatment of non-small-cell lung carcinoma is important for the EMA and FDA. However, differences exist in the evaluation of PRO data for inclusion in the label. Our analysis suggests a higher receptivity of EMA to quality of life as a global concept.