Business & Finance
Agilent Receives an Expanded FDA Approval for its Companion Diagnostic in NSCLC
22 April 2019 - - The US Food and Drug Administration has updated its approval of US-based Agilent Technologies Inc.'s (NYSE: A) PD-L1 IHC 22C3 pharmDx assay, the company said.

The assay can now be used as a companion diagnostic to identify a broader range of patients with stage III or metastatic non-small cell lung cancer (NSCLC) for first-line treatment with Keytruda, a targeted anti-PD-1 therapy manufactured by Merck and Co. (known as MSD outside the United States and Canada).

The FDA previously approved the assay to identify metastatic NSCLC patients whose tumors express PD-L1 Tumor Proportion Score ≥ 50% for first-line treatment with Keytruda.

Now, patients with stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 TPS ≥ 1% are eligible for first-line treatment.

This expanded indication enables pathologists to identify a larger population of previously untreated patients who are now eligible for treatment with Keytruda.

Lung cancer is the leading cause of cancer-related mortality in the United States, with an estimated incidence of 154,000 deaths in 2018 alone.

Among these cases, NSCLC accounts for nearly 85% of all diagnoses, and carries a 5-year survival rate of 15%.2PD-L1 is a critical biomarker for response to anti-PD-1 therapy, and pathology labs play an important role in identifying appropriate patients for these treatments.

Agilent's PD-L1 IHC 22C3 pharmDx is the first and only companion diagnostic that has been clinically validated and approved to identify NSCLC patients eligible for Keytruda.

Keytruda is a humanized monoclonal antibody that increases the ability of the body's immune system to help detect and fight tumor cells.

Keytruda blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells. Keytruda and other targeted immunotherapies are revolutionizing cancer treatment, and their therapeutic value is being demonstrated across a growing list of cancer types.

Agilent is in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy.

Agilent developed PD-L1 IHC 22C3 pharmDx in partnership with Merck and Co. PD-L1 IHC 22C3 pharmDx also helps physicians identify cervical cancer, gastric or GEJ adenocarcinoma, and urothelial carcinoma patients for treatment with Keytruda.

PD-L1 expression in NSCLC tissues is interpreted using Tumor Proportion Score. PD-L1 expression in urothelial carcinoma, cervical cancer, and gastric or GEJ adenocarcinoma tissues is interpreted using Combined Positive Score.

Agilent Technologies Inc. (NYSE: A) is a leader in life sciences, diagnostics and applied chemical markets.

With more than 50 years of insight and innovation, Agilent instruments, software, services, solutions, and people provide trusted answers to customers' most challenging questions.

The company generated revenues of USD 4.91bn in fiscal 2018 and employs 15,300 people worldwide.