Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized Phesgo (pertuzumab / trastuzumab) in combination with docetaxel for the treatment of 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.

This is written in the approval document as:

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.

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.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	HER2-positive	Invasive Breast Carcinoma	Docetaxel, Pertuzumab, Trastuzumab

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2020-12-21	European Medicines Agency	Indication received approval from the European Commission.