Agilent’s PD-L1 IHC 22C3 pharmDx Assay Approved for TNBC use in EU

Agilent’s PD-L1 IHC 22C3 pharmDx can now be used as an aid in identifying Triple-Negative Breast Cancer (TNBC) patients for treatment with KEYTRUDA® (pembrolizumab) in the European Union.

Agilent Technologies has confirmed that its PD-L1 IHC 22C3 pharmDx standardised IHC assay has received European Union approval for use in TNBC.

Anti-PD-1 therapies, such as Merck’s KEYTRUDA® (pembrolizumab), utilise PD-L1 IHC 22C3 pharmDx expression as an important biomarker that enables pathologists’ to identify patients who may be eligible for KEYTRUDA treatment. In Europe, KEYTRUDA combined with Chemotherapy is authorised for the treatment of patients with locally recurrent unresectable or metastatic TNBC who have not previously undergone chemotherapy for metastatic cancer and whose tumors express PD-L1 [Combined Positive Score (CPS)≥ 10].

The only CE-IVD–marked PD-L1 assay as an aid in identifying TNBC patients for treatment with KEYTRUDA

PD-L1 IHC 22C3 pharmDx is now the only clinical trial-proven PD-L1 assay CE-IVD–marked as an aid in identifying TNBC patients for treatment with KEYTRUDA. PD-L1 IHC 22C3 pharmDx can help physicians in Europe to identify patients for treatment with KEYTRUDA in five cancer types: non-small cell lung cancer (NSCLC), urothelial carcinoma, head and neck squamous cell carcinoma (HNSCC), esophageal cancer and triple-negative breast cancer (TNBC).

Sam Raha, president of Agilent’s Diagnostics and Genomics Group stated:

“Anti-PD-1 therapies like KEYTRUDA continue to offer new treatment options for cancer patients. This indication expansion of PD-L1 IHC 22C3 pharmDx in TNBC will allow physicians in Europe access to critical information to qualify even more patients who could benefit from these treatments. This further demonstrates Agilent’s role as a leader in developing companion diagnostics for targeted therapies.”

Breast cancer is the most common type of cancer among women, with over 530,000 new cases confirmed in Europe in 2020. TNBC accounts for around 15-20% of all diagnosed breast cancers. KEYTRUDA is a humanized monoclonal antibody that boosts the immune system’s capacity to recognize and attack tumor cells.

KEYTRUDA inhibits the PD-1 pathway, activating T-lymphocytes which can attack both tumor cells and healthy cells. Currently, KEYTRUDA and other targeted immunotherapies are revolutionizing cancer therapies, and their therapeutic potential is being recognized in a rising number of cancer types. Agilent and Merck jointly developed PD-L1 IHC 22C3 pharmDx as a companion diagnostic for KEYTRUDA.

About Agilent Technologies

Agilent is a market leader in the life sciences, diagnostics, and applied chemical industries, supplying cutting-edge technology that solves researchers’ most demanding scientific problems. In the fiscal year 2020, the company earned $5.34 billion in sales and employs 16,400 professionals throughout the world.

More information on Agilent can be found at

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA

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