OBJECTIVES: To review European Medicine Agency approvals in oncology for 2006-2012 to determine commonly used primary endpoints and endpoints based on patient reported outcomes (PROs). METHODS: The initial identification of oncology approvals was conducted in PROLabels (2006-2012). This was supplemented with a review of European Assessment Reports, Summary of Product Characteristics, Procedural Steps, Summary of the European Public Assessment Report and Scientific Discussion documents. RESULTS: There were 8 approvals in neoplasms, 3 in anemia, 4 in pain, 1 in nausea and vomiting, 1 in paroxysmal hemoglobinuria.  Primary endpoints for approval of oncology drugs included progression free survival (n=5), endpoints based on pain intensity (n=3), overall survival (n=2), hemoglobin stabilization/blood transfusion requirement (n=1), no emesis/no use of rescue medications (n=1), lesion clearance (n=1). PRO measure used included the BPI-SF, MPQ, FACIT-F, FACIT-An, FACT-L, EORTC-QLQ-C30, Pain NRS, nausea VAS, TSQM, Trial Outcomes Index and an unreported measure.  The type of PRO endpoints in the approved labeling included: Pain (n=7), HRQOL (n=6), fatigue (n=3), emetic episodes/use of rescue medications (n=1), treatment satisfaction (n=1). CONCLUSIONS: Manufacturers frequently supplement primary endpoints with supplemental PRO data.  European approvals include labeling information that is often not permitted by the FDA such as improved HRQOL.