Roche Complementary Dx, Bladder Cancer Immunotherapy Get FDA Nod | GenomeWeb

NEW YORK (GenomeWeb) – The US Food and Drug Administration today approved the Ventana PD-L1 (SP142) Assay as a complementary diagnostic for Roche's new metastatic urothelial cancer drug, called Tecentriq (atezolizumab).

The agency simultaneously approved the complementary diagnostic alongside the PD-L1 inhibitor Tecentriq, noting that the immunohistochemistry test "may help identify patients who are more likely to respond to treatment." The test is marketed by Ventana Medical Systems, a Roche subsidiary. This is the first PD-L1 inhibitor approved for bladder cancer.

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