Roche has announced approval of the VENTANA PD-L1 (SP142) Assay by the U.S. Food and Drug Administration (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 (NSCLC). The PD-L1 (SP142) assay is also indicated to identify patients with urothelial cancer (UC) 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.
Lung cancer remains the leading cause of cancer deaths with an annual estimated 12.9 percent of all new cancer cases and nearly 1.59 million deaths worldwide – about one in five cancer-related deaths. NSCLC, one of two major types of lung cancer, accounts for approximately 85 percent of all lung cancer cases. During the past three decades, lung cancer has shown the least improvement in survival rates when compared with other cancers.4
The VENTANA PD-L1 (SP142) Assay can now be performed on the VENTANA BenchMark ULTRA automated tissue staining instrument. With an established presence in laboratories globally, availability of the assay on the VENTANA BenchMark ULTRA instrument can provide broader access for patients and decrease the time spent waiting for PD-L1 test results.
"The approval of the VENTANA PD-L1 (SP142) Assay with TECENTRIQ underscores Roche's personalized healthcare strategy to provide innovative diagnostic tools that deliver valuable medical information which helps guide treatment decisions for physicians and their patients," said Ann Costello, Head of Roche Tissue Diagnostics.
Roche will continue to pursue regulatory approval for the VENTANA PD-L1 (SP142) Assay in combination with TECENTRIQ in other cancer indications and in other geographies.