FDA approves Agilent’s assay as companion diagnostic for Libtayo

23 February 2021 (Last Updated February 23rd, 2021 15:18)

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.

FDA approves Agilent’s assay as companion diagnostic for Libtayo
The expanded indication will help pathologists in detecting patients with advanced NSCLC who could be eligible for Libtayo treatment. Credit: Ed Uthman.

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.