Regulatory approval

Published by the European Medicines Agency.

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.

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