The FDA gave its approval to Roche for its Ventana PD-L1 assay to be used as a complementary diagnostic in conjunction with the company’s Tecentriq (atezolizumab) for the treatment of 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, the company said.
Roche touts the biomarker assay as the first to evaluate patient PD-L1 expression using both tumor cell and immune cell staining. By determining a patient's PD-L1 expression level, physicians can gain a better insight into the survival benefit that may be achieved from treatment with Tecentriq.
"The approval of the Ventana PD-L1 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," Ann Costello, head of Roche’s Tissue Diagnostics division, said in a statement.
According to statistics cited by the company, lung cancer is the leading cause of cancer deaths globally with an annual estimated 12.9% of all new cancer cases and nearly 1.59 million deaths. Non-small cell lung cancer accounts for about 85% of all lung cancer cases, which over the last 30 years has shown the least improvement in survival rates when compared with other cancers.
Roche said t will continue to seek regulatory approval for the Ventana PD-L1 (SP142) assay in combination with Tecentriq for other cancer indications as well as gain regulatory approval for it in other countries.