Europe is the first region to launch Agilent’s PD-L1 CE-IVD test for Urothelial Cancer (UC) globally. The test allows to identify the PD-L1 (programmed death-ligand 1) biomarker. The new indication refers to the PD-L1 IHC 28-8 pharmDx and it will assist physicians in the individuation of patient more likely to respond to BMS’s immunotherapy Opdivo (nivolumab). The drug is indicated for the treatment of previously treated locally advanced unresectable or metastatic urothelial cancer in adults after failure of prior platinum-containing therapy regardless of PD-L1 status. The new indication is supported by te data referred to a recent clinical study CA209275 (Checkmate 275).
The new indication adds to the previous one already CE marked for the test PD-L1 IHC 28-8 pharmDx: non-squamous, non-small-cell lung cancer, squamous cell carcinoma of head and neck and melanoma.