The FDA has granted accelerated approval to pembrolizumab (Keytruda, Merck) in combination with chemo-therapy for locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) that express programmed death ligand-1 (PD-L1; CPS ≥10). This approval includes the use of PD-L1 IHC 22C3 pharmDx (Dako North America) as a companion diagnostic to select patients with TNBC. This decision allows for a new treatment option for patients with TNBC who have limited options for effective therapies. This combination therapy has shown promising results in clinical trials and provides hope for improved outcomes for patients with this aggressive form of breast cancer.
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