Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized atezolizumab in combination with nab-paclitaxel for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors have PD-L1 expression >= 1% and who have not received prior chemotherapy for metastatic disease.

This is written in the approval document as:

Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumours have PD-L1 expression >= 1% and who have not received prior chemotherapy for metastatic disease.

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.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	ER negative, HER2-negative, PD-L1 >= 1%, PR negative	Invasive Breast Carcinoma	Atezolizumab, Nab-paclitaxel

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2019-08-26	European Medicines Agency	Indication received approval from the European Commission.