Merck & Co., Inc. has bolstered its chances of winning US Food and Drug Administration approval for Keytruda (pembrolizumab) in neoadjuvant triple-negative breast cancer (TNBC) with Phase III trial data showing a benefit in event-free survival, meaning that it will likely benefit from a first-to-market advantage in the setting. But the data do not support the use of a surrogate endpoint the company unsuccessfully tried to use before.
Keytruda To Enjoy First-To-Market Advantage As TNBC Approval Now More Likely
Merck & Co. unveiled event-free survival data for Keytruda in triple-negative breast cancer, following a failure earlier this year to gain approval on a surrogate endpoint.
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