FDA Expands Approval for Agilent's PD-L1 IHC 22C3 pharmDx in Lung Cancer

The U.S. Food and Drug Administration (FDA) has expanded the approval of Agilent Technologies' PD-L1 IHC 22C3 pharmDx assay for use in patients with non-small cell lung cancer (NSCLC). The assay can now be used to identify NSCLC patients with a Tumor Proportion Score (TPS) of PD-L1 expression of ≥ 50% for treatment with Libtayo® (cemiplimab-rwlc).

Lung cancer is the leading cause of cancer-related deaths in the United States, with NSCLC accounting for 85% of all lung cancer cases. PD-L1 expression is a known biomarker for response to anti-PD-1 therapy in NSCLC. This expanded indication allows pathologists to identify patients with advanced NSCLC who may be eligible for treatment with Libtayo.

"With the FDA approval of PD-L1 IHC 22C3 pharmDx as a companion diagnostic for treatment with Libtayo monotherapy in advanced NSCLC, Agilent further strengthens its ability to elevate pathologist confidence in reporting results to oncologists and bolsters our role as a global pioneer in developing companion diagnostics for targeted treatments," said Sam Raha, president of Agilent's Diagnostics and Genomics Group.

Libtayo was developed by Regeneron and Sanofi, who partnered with Agilent for the assay's use in evaluating PD-L1 expression in the pivotal EMPOWER-Lung 1 clinical trial. Agilent's test is currently the only companion diagnostic with FDA approval for this specific indication.