OBJECTIVES: The objective of analysis was to determine the types of endpoints which were basis for efficacy assessment of medicines used in specific oncological indications. The paper discusses statistical significance of results included in the marketing authorisation applications (MAAs), as well as the availability of overall survival (OS), progression-free survival (PFS) and quality of life (QOL) results after marketing authorisation. METHODS: A database of European Public Assessment Reports (EPARs) was searched. The analysis included MAAs for medicines used in oncological indications which were approved by the EMA in 2009-2017. RESULTS: The detailed analysis included 125 MAAs (62% - first-time approved, 38% - extensions). The most frequently reported endpoints in the analysed trials were OS (94.4%), PFS (92.8%) and ORR (87.2%). The results of OS were not reached (NR) in 30% of MAAs, mainly in indications characterised by longer survival. The percentage of applications based on statistically significant results in OS differed significantly between hematological and oncological indications (20% vs 65%). There were no available data regarding OS, PFS, QOL in 47.2%, 20.8% and 41.6% of MAAs. The main reason was reporting NR data (for OS) and the lack of results presented in EPAR (for QOL). Post-marketing OS data have been identified for 25.4% of MAAs. In 44 of 125 (35.2%) MAAs, a significant benefit in OS was demonstrated, with a median follow-up of 2.36 year. CONCLUSIONS: The choice of endpoints reported in clinical trials depends on the indication and subpopulation. The heterogeneity of oncological indications, in particular in terms of the length of patient survival, is noteworthy. The median follow-up of the analysis was relatively short, in 27 MAAs (21.6%), results still have not been reached (especially in hematological indications), which suggests that an increase in the percentage demonstrating a benefit in OS can be expected in the long-time follow-up.