Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to pertuzumab in combination with trastuzumab and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. This indication is based on Aphinity (NCT01358877) a multicenter, randomized, double-blind, placebo-controlled study where patients received one of the following anthracycline-based or non-anthracycline-based chemotherapy regimens: (1) cyclophosphamide, epirubicin, docetaxel, 5-fu; (2) cyclophosphamide, epirubicin, paclitaxel, 5-fu; (3) cyclophosphamide, doxorubicin, docetaxel, 5-fu; (4) cyclophosphamide, doxorubicin, paclitaxel, 5-fu; (5) doxorubicin, cyclophosphamide, docetaxel; (6) epirubicin, cyclophosphamide, docetaxel; (7) doxorubicin, cyclophosphamide, paclitaxel; (8) epirubicin, cyclophosphamide, paclitaxel; (9) carboplatin, docetaxel.

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 adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.

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.

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Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (2) HER2-positive Invasive Breast Carcinoma Cyclophosphamide, Doxorubicin, Paclitaxel, Pertuzumab, Trastuzumab
FDA (2) HER2-positive Invasive Breast Carcinoma Cyclophosphamide, Docetaxel, Epirubicin, Fluorouracil, Pertuzumab, Trastuzumab
FDA (2) HER2-positive Invasive Breast Carcinoma Cyclophosphamide, Epirubicin, Fluorouracil, Paclitaxel, Pertuzumab, Trastuzumab
FDA (2) HER2-positive Invasive Breast Carcinoma Cyclophosphamide, Docetaxel, Doxorubicin, Fluorouracil, Pertuzumab, Trastuzumab
FDA (2) HER2-positive Invasive Breast Carcinoma Cyclophosphamide, Doxorubicin, Fluorouracil, Paclitaxel, Pertuzumab, Trastuzumab
FDA (2) HER2-positive Invasive Breast Carcinoma Cyclophosphamide, Docetaxel, Epirubicin, Pertuzumab, Trastuzumab
FDA (2) HER2-positive Invasive Breast Carcinoma Cyclophosphamide, Epirubicin, Paclitaxel, Pertuzumab, Trastuzumab
FDA (2) HER2-positive Invasive Breast Carcinoma Cyclophosphamide, Docetaxel, Doxorubicin, Pertuzumab, Trastuzumab
FDA (2) HER2-positive Invasive Breast Carcinoma Carboplatin, Docetaxel, Pertuzumab, Trastuzumab

Contributions

Date Contributor Description
2024-10-30 Van Allen lab Initial access of FDA approvals
2017-12-20 Food and Drug Administration Indication received traditional approval.