Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized pertuzumab in combination with trastuzumab and chemotherapy for the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence. This indication is based on APHINITY (BO25126), a multicenter, randomized, double-blind, placebo-controlled phase 3 trial. Investigators selected one of the following chemotherapy regimes: (i) 3 or 4 cycles of FEC or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel; (ii) 4 cycles of AC or epirubicin and cyclophosphamide (EC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel; or (iii) 6 cycles of docetaxel in combination with carboplatin.

This is written in the approval document as:

Perjeta is indicated for use in combination with trastuzumab and chemotherapy in the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence.

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.

Contributions