Regulatory approval

Published by the Food and Drug Administration. Approved

PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for use in combination with 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.

This is written in the approval document.

Citation

Genentech, Inc. Phesgo (pertuzumab and trastuzumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf. Revised June 2020. Accessed October 30, 2024.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
FDA (1) HER2-positive Invasive Breast Carcinoma Cyclophosphamide, Doxorubicin, Paclitaxel, Pertuzumab, Trastuzumab
FDA (1) HER2-positive Invasive Breast Carcinoma Cyclophosphamide, Docetaxel, Epirubicin, Fluorouracil, Pertuzumab, Trastuzumab