OBJECTIVES: To review the oncology products approved in the United States and in Europe with a particular focus on the Patient-Reported Outcome (PRO) end-points appearing in the products' labels. METHODS: Oncology products approved in Europe since 1995 through the centralized procedure and in the United States since 1998 (new molecular entities) were identified directly from our internal resources resulting from a review of the EMEA and FDA websites. Using the PROLabels database, we identified the products indicated for cancer treatment and showing evidence of PRO in labeling. PROLabels is a unique on-line tool which provides information on the drug products for which the FDA and/or the EMEA have granted a PRO labeling claim RESULTS: Overall, 36 different products indicated for the treatment of cancer were identified in this review, 12 of which were approved both in Europe and in the U.S. Of these 36 approved drugs, 7 contained descriptions of Patient-Reported Outcomes in the labeling. Two drugs were approved in the US with PRO data used to assess health-related quality of life (HRQL), treatment satisfaction and subjective assessment of lesions. In Europe, 5 products used PRO data to capture HRQL, pain, and symptoms. These products were different from the US ones. Regarding the methods to measure PRO, 5 products used a defined instrument, one used a single item and another used a questionnaire which was not specified. CONCLUSION: Overall, PRO data in labeling for oncology products is not frequent (between 8 and 20% of approved products), and is comparable with the average rate over all therapeutic areas (source PROLabels). The location of PRO endpoints was mainly in the clinical studies section. An interesting finding is the lack of overlap between the American and the European PRO claims.