Roche’s Lung Cancer Assay Gets FDA Premarket Approval

Roche has received premarket approval from the FDA for its Ventana PD-L1 (SP263) assay for nonsmall-cell lung cancer (NSCLC).

The assay was used in a multi-year clinical study designed to find out how patients would respond to treatment with Roche subsidiary Genentech’s Tecentriq (atezolizumab) following traditional surgery and chemotherapy. Earlier this year, Genentech reported a 34 percent reduction in the risk of disease recurrence or death among patients treated with Tecentriq whose tumors expressed the PD-L1 protein.

The Ventana assay is a companion diagnostic test for Tecentriq, which received FDA approval on Oct. 15 to treat NSCLC. The drug’s indication is limited to adjuvant treatment following surgery and platinum-based chemotherapy.