Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that PD-L1 >= 10% TIIC 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 first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained >= 50% of tumor cells [TC >= 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering >= 10% of the tumor area [IC >= 10%] ), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

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 for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained >= 50% of tumor cells [TC >= 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering >= 10% of the tumor area [IC >= 10%] ), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

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. Genentech, Inc. Tecentriq (atezolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s027lbl.pdf. Revised May 2020. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2020-05-18	Food and Drug Administration	Indication received traditional approval.