FDA Approves Assay to Determine Eligibility for Tecentriq in Triple-Negative Breast Cancer

The FDA approved the VENTANA PD-L1 (SP142) Assay as the first companion diagnostic to aid in identifying patients with triple-negative breast cancer (TNBC) who are eligible for treatment with atezolizumab (Tecentriq) plus chemotherapy, according to Roche, the assay’s manufacturer.

The drug regimen also just received FDA approval as the first cancer immunotherapy regimen approved for breast cancer.

The VENTANA PD-L1 (SP142) Assay was developed to enhance visual contrast of tumor-infiltrating immune cell staining — which is expressed on tumor-infiltrating immune cells rather than on tumor cells themselves in TNBC. For example, the 3 most common proteins associated with breast cancer growth – estrogen receptor, progesterone receptor and HER2 – are not expressed on the tumor in this disease.

“Triple-negative breast cancer is an aggressive disease that, until now, has had limited treatment options,” Michael Heuer, CEO of Roche Diagnostics, said in a press release. “This assay plays a pivotal role in helping physicians identify patients that can benefit from Tecentriq therapy, providing better patient care. At Roche, we build on our capacity to research both targeted medicines and companion diagnostics under one roof, so we can provide the right treatment to the right patient at the right time.”