On Nov. 13, 2020, Agilent Technologies announced it had received U.S. Food and Drug Administration (FDA) approval for the use of PD-L1 IHC 22C3 pharmDx as an aid in identifying patients with triple-negative breast cancer (TNBC) for treatment with KEYTRUDA (pembrolizumab).

PD-L1 expression is a critical biomarker for response to anti-PD-1 therapies such as KEYTRUDA. The expanded use of PD-L1 IHC 22C3 pharmDx strengthens the ability of pathologists to identify patients who may be eligible for treatment with KEYTRUDA. KEYTRUDA, in combination with chemotherapy, is approved for patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥ 10] as determined by an FDA-approved test.

PD-L1 IHC 22C3 pharmDx is the only companion diagnostic that is FDA-approved to aid in the identification of TNBC patients for treatment with KEYTRUDA in combination with chemotherapy. With TNBC marking the seventh cancer type for which PD-L1 IHC 22C3 pharmDx has gained FDA approval, Agilent is further solidifying its position as a go-to partner for drug/diagnostic co-development. PD-L1 IHC 22C3 pharmDx also helps physicians identify non-small cell lung cancer (NSCLC), gastric or gastroesophageal junction (GEJ) adenocarcinoma, esophageal squamous cell carcinoma (ESCC), cervical cancer, urothelial carcinoma, and head and neck squamous cell carcinoma (HNSCC) patients for treatment with KEYTRUDA.