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Roche Nabs FDA Approval for Ventana PD-L1 Test as CDx for Libtayo

NEW YORK – Roche announced on Monday that its Ventana PD-L1 (SP263) assay has received approval from the US Food and Drug Administration for use as a companion diagnostic with Regeneron's Libtayo (cemiplimab) in lung cancer patients. 

The immunohistochemistry test detects programmed death ligand-1 protein in non-small cell lung cancer patients, the expression of which can help predict the likelihood a patient will benefit from PD-L1 or PD-1 immunotherapy drugs, Roche said in a statement. It runs on the firm's BenchMark Ultra instrument. 

Libtayo, a PD-1 inhibitor monotherapy, received FDA approval as a front-line treatment for advanced NSCLC patients with high PD-L1 expression in their tumors in 2021.

The Ventana assay received CE marking for the Libtayo indication in September and is approved by the FDA for use with multiple immunotherapy drugs for NSCLC patients including Genentech's Tecentriq (atezolizumab).