Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that PD-L1 >= 1% status confers therapeutic sensitivity to Atezolizumab in patients with Non-Small Cell Lung Cancer.

The U.S. Food and Drug Administration granted approval to atezolizumab for the adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on >= 1% of tumor cells, as determined by an FDA-approved test.

This statement is based on a regulatory approval from the Food and Drug Administration:

TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on >= 1% of tumor cells, as determined by an FDA-approved test.

Citation

Genentech, Inc. Tecentriq (atezolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761034s053lbl.pdf. Revised April 2024. Accessed October 30, 2024.