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Roche Garners Third FDA-Approved CDx Indication for Ventana PD-L1 Assay

NEW YORK (360Dx) – Roche said today it has garnered US Food and Drug Administration approval for its Ventana PD-L1 (SP142) Assay as a companion diagnostic for identifying which triple-negative breast cancer patients have increased PD-L1 expression on tumor-infiltrating immune cells and are more likely to respond to the immunotherapy Tecentriq (atezolizumab) plus chemotherapy.

The agency expanded the indication for Ventana's PD-L1 assay simultaneously with the approval of Tecentriq plus Abraxane (nab-paclitaxel) for PD-L1-positive, unresectable, locally advanced or metastatic TNBC patients who hadn't received prior treatment.

The test was originally launched in 2016 and had been previously approved by the FDA as a CDx to identify which urothelial cancer and second-line non-small cell lung cancer patients are likely respond to Tecentriq. The test runs on  Roche's BenchMark ULTRA instrumentand uses the OptiView DAB IHC Detection Kit with OptiView Amplification Kit.

TNBC is an aggressive type of cancer that lacks the common targetable receptors, estrogen, progesterone, or HER2. Patients with this type of breast cancer have poor prognosis and lack treatment options. "This assay plays a pivotal role in helping physicians identify patients that can benefit from Tecentriq therapy, providing better patient care," said Roche Diagnostics CEO Michael Heuer in a statement.   

The FDA's latest accelerated approval for Tecentriq plus chemotherapy is based on data from the Phase III IMpassion130 study, which showed that PD-L1-positive, advanced TNBC patients who received the regimen experienced median progression-free survival of 7.4 months compared to 4.8 months for those who received just nab-paclitaxel. Overall survival data was immature at the time Roche submitted this data to the FDA and will be shared at an upcoming meeting. The study didn't reveal any new safety signals with Tecentriq plus chemo.