Posted by Michael Wonder on 30 Oct 2016
Roche announces FDA approval for Ventana PD-L1 (SP142) assay to support immunotherapy treatment decisions in lung cancer
27 October 2016 - First FDA-approved test to support patient treatment decisions for Tecentriq (atezolizumab) in non-small-cell lung cancer.
Roche today announced approval of the Ventana PD-L1 (SP142) assay by the U.S. FDA as a complementary diagnostic to identify PD-L1 expression levels in patients considering treatment with the FDA-approved Roche cancer immunotherapy Tecentriq (atezolizumab) for previously treated metastatic non-small-cell lung cancer.
The PD-L1 (SP142) assay is also indicated to identify patients with urothelial cancer who may benefit from treatment with Tecentriq.
This innovative biomarker assay is the first to evaluate patient PD-L1 expression using both tumor cell and immune cell staining. Determining a patient’s PD-L1 expression level can provide insight into the survival benefit that may be achieved from treatment with Tecentriq.
