Posted by Michael Wonder on 03 May 2017
Roche receives FDA approval for complementary PD-L1 (SP263) biomarker test in urothelial carcinoma
2 May 2017 - Use of the VENTANA PD-L1 (SP263) assay to determine PD-L1 expression in urothelial carcinoma may help to inform the likelihood of responding to Imfinzi (durvalumab) immunotherapy.
Roche today announced approval of the VENTANA PD-L1 (SP263) assay by the US FDA as a complementary diagnostic to provide PD-L1 status for patients with locally advanced or metastatic urothelial carcinoma who are being considered for treatment with the FDA-approved anti-PD-L1 immunotherapy Imfinzi (durvalumab, AstraZeneca).
The test evaluates patient PD-L1 status using both tumour and immune cell staining and scoring within the tumour 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 tumours can help identify patients most likely to benefit from immunotherapy.
