Notes
As a recent example, MSD’s approval application of pembrolizumab (Keytruda) for treatment of esophageal cancer was initially for the all-comer population. However, the European Medicines Agency (EMA) accepted the indication in patients whose tumors express PD-L1 with a CPS ≥ 10 only, after concluding that the clinical effect on patients with CPS < 10 was not significant [2].
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European Medicines Agency. Keytruda: EPA—Public assessment report 2021. Available from: https://www.ema.europa.eu/en/documents/variation-report/keytruda-h-c-3820-ii-0097-epar-assessment-report-variation_en.pdf
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Luís, A.B.D., Seo, M.K. Reply to comment on “Demonstrating the value of cancer biomarkers at the population”. Eur J Health Econ 23, 757–758 (2022). https://doi.org/10.1007/s10198-022-01475-5
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DOI: https://doi.org/10.1007/s10198-022-01475-5