Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that v::ALK 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 treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving atezolizumab.
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 treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ.
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/2017/761034s001lbl.pdf. Revised April 2017. Accessed October 6, 2026.
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2024-10-30 | Van Allen lab | Initial access of FDA approvals |
| 2017-04-17 | Food and Drug Administration | Indication received traditional approval. |