FDA approves Agilent’s assay as companion diagnostic for Libtayo

The US Food and Drug Administration (FDA) has approved Agilent Technologies PD-L1 IHC 22C3 pharmDx assay for expanded use in patients with non-small cell lung cancer (NSCLC) as a companion diagnostic.

Currently, the assay can be used in detecting NSCLC patients with tumour PD-L1 expression of Tumor Proportion Score (TPS) greater than or equal to 50% for treatment with Libtayo (cemiplimab-rwlc).

PD-L1 expression is a biomarker for anti-PD-1 therapy response in NSCLC.

The latest expanded indication will help pathologists to detect patients with advanced NSCLC who could be eligible for Libtayo treatment.

Currently, PD-L1 IHC 22C3 pharmDx is the only FDA-approved companion diagnostic for this purpose.

Agilent Diagnostics and Genomics Group president Sam Raha said: “Anti-PD-1 therapies, including Libtayo, continue to broaden the potential for the treatment of patients across different cancer types.

“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.”

Regeneron and Sanofi developed Libtayo and collaborated with Agilent for using the assay in assessing PD-L1 expression in patients in the EMPOWER-Lung 1 clinical trial.

PD-1 immunotherapies such as Libtayo provide treatment options to advanced NSCLC patients. For those with stage IVA–IVB disease, the 60-month overall survival rate is 0%-10%.

A fully human monoclonal antibody, Libtayo is directed at the immune checkpoint receptor PD-1 on T-cells. It binds to PD-1 to potentially inhibit cancer cells from using the PD-1 pathway for suppressing T-cell activation.

Last week, Agilent launched a new immunoassay kit for the qualitative detection of SARS-CoV-2 immunoglobulin G (IgG) antibodies in human serum or plasma.