Regulatory approval

Published by the European Medicines Agency.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ER negative, HER2-negative, PD-L1 >= 1%, PR negative	Invasive Breast Carcinoma	Atezolizumab, Nab-paclitaxel