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Clearer Definitions of Added Benefit, Unmet Needs Could Improve EU Oncologic Drug Approval Process

Investigators emphasize the importance of firming a widely understood definition of unmet needs in cancer care due to their impact on drug approvals.

EU Approves Many Oncology Drugs Without Proof of Benefit

Added benefit and revenues of oncology drugs approved by the European Medicines Agency between 1995 and 2020: retrospective cohort study

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

High cost oncology drugs without proof of added benefit are burdening health systems

Retrospective Study Suggests Large Proportion of EU-Approved Oncology Drugs Offer Minimal or No Added Benefit

Most oncology drugs approved by the EMA recover research and development costs within a few years, even if the drug is providing little added benefit.