Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized pertuzumab in combination with trastuzumab and 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:

Perjeta is indicated for use in combination with trastuzumab and 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. Perjeta (pertuzumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/perjeta-epar-product-information_en.pdf. Revised December 2021. 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
2013-03-04	European Medicines Agency	Indication received approval from the European Commission.