Agilent Gains EU Approval for PD-L1 Test in Ovarian Cancer
Agilent Technologies has received European Union certification for its PD-L1 IHC 22C3 pharmDx diagnostic test. The approval supports treatment decisions for patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
Agilent Technologies announced it has received European Union (EU) certification for its PD-L1 IHC 22C3 pharmDx diagnostic test. This approval allows the test to be used in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who may be candidates for treatment with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy.
The test, identified as Code SK006, enables pathologists to assess PD-L1 expression, supporting informed decisions in a disease area with limited treatment options. This marks the eighth CE-marked companion diagnostic indication for PD-L1 IHC 22C3 pharmDx in the EU.
Agilent stated the approval is supported by data from the KEYNOTE-B96/ENGOT-ov65 clinical trial. The trial evaluated PD-L1 expression in these specific cancer types to identify patients eligible for pembrolizumab treatment, particularly in the platinum-resistant setting.
Merck is known as MSD outside the United States and Canada. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC. The PD-L1 IHC 22C3 pharmDx test was developed by Agilent in partnership with Merck.