資料來源： https://www.pharmacychoice.com/News/article.cfm?Article_ID=1632283

Roche (RHHBY) announced approval of the VENTANA PD-L1 (SP142) Assay by the U.S. Food and Drug Administration as a complementary diagnostic to identify PD-L1 expression levels in patients considering treatment with the FDA-approved Roche cancer immunotherapy TECENTRIQ or atezolizumab for previously treated metastatic non-small cell lung cancer or NSCLC.

The PD-L1 (SP142) assay is also indicated to identify patients with urothelial cancer or UC who may benefit from treatment with TECENTRIQ.

The 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.

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.

Roche noted that it 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.