Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to pertuzumab in combination with trastuzumab and chemotherapy for the neoadjuvant treatment patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. This indication is based on Berenice (NCT02132949), a two-arm randomized study where HER2-positive was defined as a score of 3+ IHC or ISH amplification ratio of 2.0 or greater, as determined by a central laboratory. Patients received two potential chemotherapy regimens as part of the combination therapy: cyclophosphamide, doxorubicin, and paclitaxel; or cyclophosphamide, docetaxel, epirubicin, and 5-fu.

This is written in the approval document as:

PERJETA is a HER2/neu receptor antagonist indicated for use in combination with trastuzumab and chemotherapy as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer.

Citation

Genentech, Inc. Perjeta (pertuzumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125409s124lbl.pdf. Revised January 2020. Accessed October 30, 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	Cyclophosphamide, Doxorubicin, Paclitaxel, Pertuzumab, Trastuzumab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Cyclophosphamide, Docetaxel, Epirubicin, Fluorouracil, Pertuzumab, Trastuzumab