Regulatory challenges: is a surrogate endpoint instead of overall survival enough for regulatory approval of (neo)adjuvant cancer treatment? The Swissmedic perspective.

J Clin Oncol

21 September 2023 - From a regulator's point of view, a market authorisation can only be granted with a positive benefit-risk (BR) balance. 

In collaboration with oncologists from the Swiss Human Medicines Expert Committee, we would like to highlight five essential points as a SMC position to inform and guide our current regulatory decision making for (neo)adjuvant oncology drugs:

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Michael Wonder

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Michael Wonder