Roche announced that the U.S. Food and Drug Administration (FDA) has granted priority review for Tecentriq (atezolizumab) as an adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumors express PD-L1≥1%, as determined by an FDA-approved test.
The FDA is expected to make a decision on approval by December 2021.
Roche said the application is based on disease-free survival (DFS) results from an interim analysis of a Phase III study, which showed that treatment with Tecentriq, following surgery and platinum-based chemotherapy, reduced the risk of disease recurrence or death (DFS) by 34% in people with Stage II-IIIA NSCLC whose tumors express PD-L1≥1%, compared with best supportive care (BSC).
Tecentriq is a monoclonal antibody designed to bind with a protein called Programmed Death Ligand-1 (PD-L1), which is expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells.
