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Agilent's test gets US FDA expanded approval for use in esophageal cancer

Santa Clara, Calif.-based Agilent Technologies Inc.'s diagnostic test has won the U.S. Food and Drug Administration's approval for a sixth cancer type.

The expanded approval was granted for the company's PD-L1 IHC 22C3 pharmDx, which can help to identify patients with a type of esophageal cancer who are eligible for treatment with Merck & Co. Inc.'s Keytruda.

The esophagus is the muscular tube connecting the throat and the stomach. Esophageal squamous cell carcinoma, or ESCC, arises from squamous cells that line the respiratory and digestive tracts, among other places. It accounts for about 30% of all esophageal cancers diagnosed in the U.S., according to an estimate.

Keytruda, or pembrolizumab, is approved to treat patients with ESCC whose disease has returned or has spread to other parts of the body on or after one initial line of systemic therapy, and whose tumors express the PD-L1 protein. The therapy works by boosting the immune system's ability to kill cancer cells by blocking healthy cells' PD-1 protein from linking up with a partner arm on the surface of cancer cells.

The PD-L1 IHC 22C3 pharmDx is the only FDA-approved companion diagnostic test for identifying ESCC patients for second-line treatment with Keytruda.

Agilent developed the diagnostic test in collaboration with the Kenilworth, N.J.-based pharmaceutical giant Merck.