FDA Approves Keytruda in Both Adjuvant and Neoadjuvant Setting in High-Risk Early-Stage TNBC
In July 2021, the US FDA approved pembrolizumab (Keytruda) for high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery. This approval was based on Phase III KEYNOTE-522 trial (NCT03036488) and became the first immunotherapy regimen to be approved in high-risk early-stage TNBC, marking a milestone for breast cancer patients. Earlier in February 2021, the agency rejected Merck’s application to approve the drug for this population and requested...