Posted by Michael Wonder on 22 Sep 2023
Regulatory challenges: is a surrogate endpoint instead of overall survival enough for regulatory approval of (neo)adjuvant cancer treatment? The Swissmedic perspective.
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:
