Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that ER negative, HER2-negative, PD-L1 >= 1%, PR negative status confers therapeutic sensitivity to Atezolizumab, Nab-paclitaxel in patients with Invasive Breast Carcinoma.

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

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.