Tumor Indication* | Intended Use | PD-L1 Expression Clinical Cut off |
---|---|---|
nsNSCLC | PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC and SCCHN may be associated with enhanced survival from OPDIVO® (nivolumab). | ≥1%, ≥5%, ≥10% |
SCCHN | ≥1% | |
UC | PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in UC may be associated with enhanced response rate from OPDIVO®. | ≥1% |
Melanoma | Positive PD-L1 status as determined by PD-L1 IHC 28-8 pharmDx in melanoma is correlated with the magnitude of the treatment effect on progression-free survival from OPDIVO®. | ≥1% |
*For details on staining interpretation, refer to section 13 of the product insert and indication specific PD-L1 IHC 28-8 pharmDx Interpretation Manuals.