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Objectives To evaluate the added benefit and revenues of oncology drugs, explore their association, and investigate potential discrepancies between added benefit and revenues across different approval pathways of the European Medicines Agency (EMA). Design Retrospective cohort study. Setting Oncology drugs and their indications approved by the EMA between 1995 and 2020. Main outcome measures Added benefit was evaluated using ratings published by seven organisations: health technology assessment agencies from the United States, France, Germany, and Italy, two medical oncology societies, and a drug bulletin. All retrieved ratings were recategorised using a four point ranking scale to indicate negative or non-quantifiable, minor, substantial, or major added benefit. Revenue data were extracted from publicly available financial reports and compared with published estimates of research and development (R&D) costs. Finally, the association between added benefit and revenue was evaluat

United statesRick vremanLourenst bloemDaan marselisJan willem versteegWimg goettschFrancine brinkhuisGemeinsamer bundesausschussEuropean medicines agencyEuropean commission union registerJan willem versteeg utrecht universityWorld health organizationUtrecht universityAmerican society of clinical oncologyOslo medicines initiativeEuropean union