The US Food and Drug Administration has approved Agilent Technologies' companion diagnostic to identify patients whose tumors express programmed death ligand 1 and who may be eligible for treatment with nivolumab (Opdivo) or nivolumab and hyaluronidase-nvhy (Opdivo Qvantig), according to a company press release. The approval applies to patients with esophageal squamous cell carcinoma, gastric tumors, gastroesophageal junction tumors, and esophageal adenocarcinoma.

The companion diagnostic,  programmed death ligand 1 (PD-L1) IHC 28-8 pharmDx assay, is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution. According to the company, the assay is a diagnostic aid for detecting PD-L1 expression using a Combined Positive Score of 1 or greater in patients being considered for treatment with nivolumab or nivolumab and hyaluronidase-nvhy. The Combined Positive Score measures PD-L1 staining in tumor cells and immune cells relative to the total number of viable tumor cells.

“By expanding the indications for PD-L1 IHC 28-8 pharmDx, we are supporting pathologists and clinicians with an FDA-approved test designed to help guide treatment decisions for patients with gastric and esophageal cancers,” said Majken Nielsen, vice president and general manager of Agilent's Clinical Diagnostics Division.

The press release stated that esophageal cancer is the 11th most common cancer worldwide, with more than 510,000 new cases each year, and is the 7th leading cause of cancer mortality, accounting for more than 445,000 deaths annually. Gastric cancer is the fifth most common cancer worldwide, with approximately 968,000 new cases each year, and is the fifth leading cause of cancer mortality, accounting for approximately 660,000 deaths annually. The company also cited American Cancer Society estimates reporting overall 5-year survival rates of 22% for esophageal cancer and 38% for gastric cancer.

Agilent stated that the PD-L1 IHC 28-8 pharmDx assay was developed in partnership with Bristol Myers Squibb as part of the clinical development program supporting nivolumab. According to the company, the CheckMate-648 and CheckMate-649 studies demonstrated improvements in overall survival and progression-free survival among patients with the listed tumor types treated with Opdivo and Opdivo Qvantig.

Source: Agilent Technologies