FDA grants priority review treatment for some people with early non-small cell lung cancer

Aug. 5, 2021

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.

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