Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (EOC)
The U.S. FDA approved PD-L1 IHC 22C3 pharmDx (Code SK006) as the only companion diagnostic to identify first-line patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC) expressing PD-L1 (CPS ≥1) eligible for KEYTRUDA (pembrolizumab).
This marks the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx with KEYTRUDA, following NSCLC, ESCC, cervical cancer, HNSCC, TNBC, and gastric/GEJ adenocarcinoma.
Approval supported by KEYNOTE-B96 clinical trial evaluating PD-L1 expression in EOC.
Developed by Agilent in partnership with Merck; announced February 10-11, 2026.
Enables pathologists to assess PD-L1 at diagnosis for informed treatment in EOC, where options are limited; U.S. ovarian cancer had ~12,730 deaths in 2025 and 51.6% 5-year survival (2015-2021).