Regulatory approval

Published by the European Medicines Agency.

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 is written in the approval document as:

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	PD-L1 >= 50%, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Atezolizumab