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Agilent PD-L1 Assay Gets FDA Approval as Metastatic NSCLC Companion Diagnostic

NEW YORK – Agilent Technologies announced on Monday it has received approval from the US Food and Drug Administration for its PD-L1 IHC 28-8 pharmDx as a companion diagnostic for expanded use in non-small cell lung cancer (NSCLC).

The assay was approved to help identify patients with metastatic NSCLC who are appropriate for treatment with nivolumab and ipilimumab (Bristol Myers Squib's Opdivo and Yervoy). According to Agilent, based on the results of the Phase 3 Checkmate-227 clinical trial, nivolumab and ipilimumab in combination were approved by the FDA as first-line treatments for patients with metastatic NSCLC whose tumors express PD-L1 as determined by an FDA-approved test.

PD-L1 IHC 28-8 was developed by Agilent in collaboration with Bristol Myers Squibb and was previously approved as a complementary in vitro diagnostic for non-squamous non-small cell lung cancer, and cancers, such as squamous cell carcinoma of the head and neck, and urothelial carcinoma.

In April, Agilent received approval for the assay from the FDA as a companion diagnostic for pembrolizumab (Merck's Keytruda) also for NSCLC.