FDA Issues Complete Response Letter to Merck for Keytruda in Early TNBC Asking for More Data

NEW YORK – Merck said after the close of the market on Monday that the US Food and Drug Administration has, at this time, decided not to approve pembrolizumab (Keytruda) as a neoadjuvant and adjuvant treatment for high-risk, early-stage triple-negative breast cancer (TNBC).