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. Genentech, Inc. Tecentriq (atezolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034Orig1s042lbl.pdf. Revised October 2021. Accessed October 6, 2026.
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2024-10-30 | Van Allen lab | Initial access of FDA approvals |
| 2021-10-15 | Food and Drug Administration | Indication received traditional approval. |