This article has been updated to include companion diagnostic approval information.
NEW YORK – Genentech said on Monday that the US Food and Drug Administration has approved atezolizumab (Tecentriq) as a first-line treatment for metastatic non-small cell lung cancer that expresses PD-L1 in 50 percent or more of tumor cells and has no genetic aberrations in EGFR or ALK.
The FDA also approved the VENTANA PD-L1 SP142 Assay by Ventana Medical Systems as a companion diagnostic device for selecting NSCLC patients for treatment with atezolizumab.