FDA Approves Agilent PD-L1 Test for First-Line Ovarian Cancer Therapy

Reuters
Feb 11
FDA Approves Agilent PD-L1 Test for First-Line Ovarian Cancer Therapy

Agilent Technologies Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its PD-L1 IHC 22C3 pharmDx, Code SK006, as a companion diagnostic to aid in identifying first-line patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC) whose tumors express PD-L1. This approval enables the identification of patients who may be eligible for treatment with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy. The approval is based on results from the KEYNOTE-B96 clinical trial and marks the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx, Code SK006, for use with KEYTRUDA.

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