Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that PD-L1 >= 50%, 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 adjuvant treatment following complete resection and platinum-based chemotherapy of adult patients with non-small cell lung cancer with a high risk of recurrence whose tumors have PD-L1 expression on >= 50% of tumor cells (TC) and who do not have EGFR mutant or ALK-positive NSCLC.

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

Tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on >= 50% of tumour cells (TC) 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
2022-06-07	European Medicines Agency	Indication received approval from the European Commission.