Agilent Technologies Inc announced that the US Food and Drug Administration (FDA) has approved its Dako PD-L1 IHC 22C3 pharmDx assay for expanded use.

Physicians in the United States can now gain valuable information to help them identify cervical cancer patients who are most likely to benefit from treatment with Keytruda, an anti-PD1 immunotherapy manufactured by Merck (known as MSD outside the United States and Canada).

PD-L1 IHC 22C3 pharmDx is now the first FDA-approved IHC test for determining PD-L1 expression in cervical cancer and is the first FDA-approved companion diagnostic to identify patients with cervical cancer for treatment with Keytruda. This follows an initial FDA approval for PD-L1 IHC 22C3 pharmDx in non-small cell lung cancer and a subsequent expanded approval to include gastric or gastroesophageal junction adenocarcinoma.

“PD-L1 is a critical biomarker for identifying patients who are likely to derive benefit from anti-PD-1 immunotherapy, and with an increasingly complex marketplace, pathologists look to Agilent as the clear leader to provide accurate and reliable PD-L1 testing,” said Sam Raha, president of Agilent's Diagnostics and Genomics Group. “This expansion of use for the Dako PD-L1 IHC 22C3 pharmDx assay gives patients with cervical cancer the possibility of having their tumor sample tested for PD-L1 expression, and determining eligibility for treatment with Keytruda.”

Cervical cancer is the third most common gynecologic cancer in the United States, with 13,000 cases expected to be diagnosed this year alone. The overall survival rate has not improved in the past 40 years, despite advancements in prevention and early detection. Cervical cancer patients previously had few treatment options other than highly toxic chemotherapy.

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, with their therapeutic value being demonstrated across a growing list of cancer types.

Agilent is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy. Agilent developed PD-L1 IHC 22C3 pharmDx in partnership with Merck & Co.