Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that PD-L1 >= 10% TIIC, Wild type ALK, and Wild type EGFR status confers therapeutic sensitivity to Atezolizumab in patients with Non-Small Cell Lung Cancer.

The European Medicines Agency (EMA) has authorized atezolizumab for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression >= 50% tumor cells or >= 10% tumor-infiltrating immune cells (IC) and who do not hvae EGFR mutant or ALK-positive NSCLC.

This statement is based on a regulatory approval from the European Medicines Agency:

Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumours have a PD-L1 expression >= 50% TC or >= 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC.

Citation

Roche Registration GmbH. Tecentriq (atezolizumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf. Revised March 2024. Accessed March 23, 2024.

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2021-04-30	European Medicines Agency	Indication received approval from the European Commission.