Abstract

The tumour agnostic label for larotrectinib and entrectinib as approved by the European Medicines Agency announced a new era of personalized medicine in Europe. This study assessed whether future innovative personalized treatments entering the European market may learn lessons from tumour agnostic products, by exploring and comparing the variety of uncertainty considerations by different stakeholders (clinical trial design, regulators, health technology assessment (HTA), payers and clinical guideline developers) throughout the lifecycle?

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