Agilent PD-L1 assay receives FDA approval for use as a companion diagnostic

Agilent Technologies Inc. has announced that the U.S. Food and Drug Administration has approved the company’s PD-L1 IHC 28-8 pharmDx for expanded use in non-small cell lung cancer (NSCLC).

Now, physicians will be able to use the PD-L1 IHC 28-8 pharmDx assay as an aid in identifying patients with metastatic NSCLC for treatment with the dual immunotherapy combination of Opdivo (nivolumab) and Yervoy (ipilimumab), manufactured by Bristol Myers Squibb. Based on the results of the Phase 3 CheckMate -227 clinical trial, Opdivo in combination with Yervoy was approved as first-line treatment for patients with metastatic NSCLC whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test.

“The expanded use of PD-L1 IHC 28-8 pharmDx will give physicians in the USA critical information to inform first-line treatment decisions for patients with metastatic non-small cell lung cancer,” said Sam Raha, president of Agilent's Diagnostics and Genomics Group.

Agilent developed PD-L1 IHC 28-8 pharmDx in 2016 through a collaboration with Bristol Myers Squibb, and it has been previously approved as a complementary in vitro diagnostic for non-squamous non-small cell lung cancer, as well as other forms of cancer, including, squamous cell carcinoma of the head and neck, and urothelial carcinoma.

Lung cancer is the most commonly diagnosed cancer worldwide across both sexes, causing 18.4% of all cancer deaths, with an estimated two million new cases reported in 2018. NSCLC accounts for 80%–90% of lung cancers, and 75% of NSCLC patients are diagnosed in the advanced stage.

Opdivo^® and Yervoy^® are registered trademarks of Bristol-Myers Squibb Company.

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