Phesgo (pertuzumab / trastuzumab) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	2
Phesgo is indicated for use in combination with chemotherapy in the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence.	7
Phesgo is indicated for use in combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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