Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized Phesgo (pertuzumab / trastuzumab) in combination with chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence. This indication is based on BERENICE (WO29217), a nonrandomized, open-label, multicenter, multinational, phase 2 clinical study where the treatment regimes were either (i) doxoruicin and cyclophosphamide followed by pertuzumab in combination with trastuzumab and paclitaxel or (ii) pertuzumab in combination with trastuzumab and docetaxel.

This is written in the approval document as:

Phesgo is indicated for use in combination with chemotherapy in the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.

Citation

Roche Registration GmbH. Phesgo (pertuzumab / trastuzumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/phesgo-epar-product-information_en.pdf. Revised March 2022. Accessed March 22, 2024.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Cyclophosphamide, Doxorubicin, Paclitaxel, Pertuzumab, Trastuzumab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Docetaxel, Pertuzumab, Trastuzumab