Agilent Receives Expanded FDA Approval for PD-L1 IHC 22C3 pharmDx in Triple-Negative Breast Cancer

In Clinical Studies News by Barbara Jacoby


Agilent Technologies Inc. (NYSE: A) today announced it has received 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.

“Anti-PD-1 therapies, including KEYTRUDA, continue to offer new treatment options for a growing population of cancer patients,” said Nina Green, vice president and general manager of Companion Diagnostics at Agilent. “With the expanded FDA approval of PD-L1 IHC 22C3 pharmDx in TNBC, physicians will be able to access critical information to qualify even more patients who could benefit from these treatments. This new approval reinforces Agilent’s role as a worldwide leader in developing companion diagnostics for targeted therapies.”

Breast cancer is the most common type of cancer among women, with 276,480 new cases estimated to be diagnosed in the United States in 2020. 1 Approximately 10% of breast cancer diagnoses are TNBC. 2

KEYTRUDA is a humanized monoclonal antibody that enhances the ability of the immune system to detect and fight tumor cells. KEYTRUDA blocks the PD-1 pathway, thereby activating T lymphocytes that may affect both tumor cells and healthy cells. KEYTRUDA and other targeted immunotherapies are changing cancer treatment, and their therapeutic value is being realized across a growing list of cancer types. PD-L1 IHC 22C3 pharmDx was developed by Agilent as a companion diagnostic for KEYTRUDA in partnership with Merck (known as MSD outside the United States and Canada).

About Agilent Technologies

Agilent Technologies Inc. (NYSE: A) is a global leader in life sciences, diagnostics, and applied chemical markets. In its 20th year as an independent company delivering insight and innovation toward improving the quality of life, Agilent instruments, software, services, solutions, and people provide trusted answers to customers’ most challenging questions. The company generated revenue of $5.16 billion in fiscal 2019 and employs 16,300 people worldwide. Information about Agilent is available at To receive the latest Agilent news, subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn, Twitter, and Facebook.


1. Cancer of the Breast (Female) – Cancer Stat Facts. (accessed Oct 26, 2020)

2. Triple-negative breast cancer: is there a treatment on the horizon? (accessed Nov 12, 2020)

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