Agilent Receives EU Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

Approval expands PD-L1 testing to support treatment decisions with KEYTRUDA^® (pembrolizumab)

SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced it has received European Union (EU) certification for PD-L1 IHC 22C3 pharmDx, Code SK006, as a companion diagnostic indicated to aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, whose tumors express PD-L1 and who may be eligible for treatment with KEYTRUDA^® (pembrolizumab), Merck’s (known as MSD outside the United States and Canada) anti-PD-1 therapy.

PD-L1 IHC 22C3 pharmDx, Code SK006, enables pathologists to assess PD-L1 expression to identify patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who may be eligible for treatment with pembrolizumab, in accordance with the approved product labelling, supporting informed treatment decisions in a disease where therapeutic options remain limited for many patients. This approval marks the eighth CE-marked companion diagnostic indication currently available for PD-L1 IHC 22C3 pharmDx, Code SK006 in the EU.

“Expanding access to precision oncology across regions is essential to improving patient outcomes,” said Majken Nielsen, vice president and general manager of Agilent’s Clinical Diagnostics Division. “This EU approval builds on our commitment to deliver high-quality companion diagnostics and enables laboratories to support more informed treatment decisions for patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.”

PD-L1 expression in epithelial ovarian, fallopian tube, or primary peritoneal carcinoma was evaluated using PD-L1 IHC 22C3 pharmDx, Code SK006, in the KEYNOTE-B96/ENGOT -ov65 clinical trial, supporting its use as an aid in identifying patients who may be eligible for treatment with pembrolizumab in the platinum-resistant setting.

In addition, PD-L1 IHC 22C3 pharmDx, Code SK006, is indicated in the EU to help physicians identify patients across several tumor types, including non-small cell lung cancer (NSCLC), esophageal cancer, cervical cancer, head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), gastric or gastroesophageal junction (GEJ) adenocarcinoma and urothelial carcinoma, who may be eligible for treatment with KEYTRUDA^®, in accordance with the approved product labelling.

PD-L1 IHC 22C3 pharmDx, Code SK006, was developed by Agilent in partnership with Merck (known as MSD outside of the United States and Canada) as a companion diagnostic for KEYTRUDA^®.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

See the KEYTRUDA^® product label for specific clinical circumstances guiding therapy

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