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Agilent Gets FDA Approval of Expanded Use of CDx Assay for Keytruda

NEW YORK – Agilent Technologies on Tuesday said it gained US Food and Drug Administration approval of the firm's PD-L1 companion diagnostic assay for use in identifying gastric or gastroesophageal junction adenocarcinoma patients for a combination treatment with Merck's Keytruda (pembrolizumab) checkpoint inhibitor.

Santa Clara, California-based Agilent said the PD-L1 IHC 22C3 PharmDx assay is now approved by the FDA to identify which patients are suitable for treatment with Keytruda in combination with chemotherapy and trastuzumab plus fluoropyrimidine. With this new approval, the immunohistochemistry companion diagnostic is approved for use to help guide treatment with Keytruda for six cancer types, the other five being non-small cell lung cancer, esophageal squamous cell carcinoma, cervical cancer, head and neck squamous cell carcinoma, and triple-negative breast cancer.

"PD-L1 expression is a critical biomarker for response to anti-PD-1 therapies such as Keytruda," Lou Welebob, VP and general manager of Agilent's Pathology Division, said in a statement. "This endorsement underscores Agilent's leadership in the development of companion diagnostics for groundbreaking anti-PD-1 therapies."

Last week, the FDA limited use of Keytruda in combination with Genentech's HER2-targeted Herceptin (trastuzumab) and chemotherapy for treatment of patients with advanced gastric cancer. The treatment is only available following determination with an FDA-approved test that a patient's tumors express PD-L1. The agency determined that patients with PD-L1-expressing cancers benefited the most from the combination of Keytruda, Herceptin, and chemotherapy.

Agilent has also gained in August CE-IVDR marking for the immunohistochemistry companion diagnostic assay for use to aid identification of patients with NSCLC, urothelial carcinoma, head and neck squamous cell carcinoma, esophageal cancer, or triple-negative breast cancer who would benefit from Keytruda, and patients with NSCLC who would benefit from Regeneron's Libtayo (cemiplimab).