The FDA approved pembrolizumab (Keytruda, Merck) 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.
The FDA also granted regular approval to pembrolizumab in combination with chemotherapy for patients with locally recurrent unresectable or metastatic TNBC whose tumors express programmed death ligand-1 (PD-L1) with a combined positive score ≥10 as