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Agilent Gets CE Mark for Expanded Use of PD-L1 CDx in Triple-Negative Breast Cancer

NEW YORK ─ Agilent Technologies said Thursday that it has obtained CE marking for the expanded use of its PD-L1 IHC 22C3 pharmDx CDx to identify patients with triple-negative breast cancer in the European Union.

Santa Clara, California-based Agilent noted PD-L1 expression is a critical biomarker for response to anti-PD-1 therapies such as pembrolizumab (Merck's Keytruda), a monoclonal antibody that increases the ability of the immune system to detect and fight tumor cells.

The expanded use of PD-L1 IHC 22C3 pharmDx strengthens pathologists' ability to identify patients who may be eligible for treatment with pembrolizumab, Agilent said. In Europe, pembrolizumab combined with chemotherapy is indicated for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumors express PD-L1 and who have not received prior chemotherapy for metastatic disease.

Agilent developed PD-L1 IHC 22C3 pharmDx as a CDx for pembrolizumab in partnership with Kenilworth, New Jersey-based Merck. Agilent noted the test can now help physicians in Europe identify patients for treatment with pembrolizumab in five cancer types: non-small cell lung cancer, urothelial carcinoma, head and neck squamous cell carcinoma, esophageal cancer, and triple-negative breast cancer.

Agilent received CE marking for the expanded use of PD-L1 IHC 22C3 pharmDx companion diagnostic assay in patients with esophageal cancer in August.