The FDA granted accelerated approval to pembrolizumab (Keytruda, Merck) in combination with chemo-therapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express programmed death ligand-1 (PD-L1; combined positive score [CPS] ≥10), as determined by an FDA-approved test.
The agency also approved the PD-L1 IHC 22C3 pharmDx (Dako North America) as a companion diagnostic to support selection of patients with TNBC