FDA approves Ventana PD-L1 (SP263) Assay for bladder cancer- Roche

Roche announced approval of the Ventana PD-L1 (SP263) Assay by the US Food and Drug Administration (FDA) as a complementary diagnostic to provide PD-L1 status for patients with locally advanced or metastatic urothelial carcinoma (mUC) who are being considered for treatment with the FDA-approved anti-PD-L1 immunotherapy IMFINZI (durvalumab) from AstraZeneca. The test evaluates patient PD-L1 status using both tumor and immune cell staining and scoring within the tumor microenvironment, providing clinicians with information that may guide treatment decisions. PD-L1 is a protein involved in the suppression of the immune system, which can impact the body's ability to fight cancer. Understanding the expression of PD-L1 in tumors can help identify patients most likely to benefit from immunotherapy.