Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to Phesgo (pertuzumab and trastuzumab) in combination with 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. The FeDeriCa study (NCT03493854) demonstrated comparable pharmacokinetics and safety profiles between Phesgo and intravenous pertuzumab and intravenous trastuzumab.

This is written in the approval document as:

PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for use in combination with chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.

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.

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, Docetaxel, Epirubicin, Fluorouracil, Pertuzumab, Trastuzumab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Carboplatin, Docetaxel, Pertuzumab, Trastuzumab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Cyclophosphamide, Epirubicin, Fluorouracil, Paclitaxel, Pertuzumab, Trastuzumab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Cyclophosphamide, Docetaxel, Doxorubicin, Fluorouracil, Pertuzumab, Trastuzumab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Cyclophosphamide, Doxorubicin, Fluorouracil, Paclitaxel, Pertuzumab, Trastuzumab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Cyclophosphamide, Docetaxel, Epirubicin, Pertuzumab, Trastuzumab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Cyclophosphamide, Epirubicin, Paclitaxel, Pertuzumab, Trastuzumab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Cyclophosphamide, Docetaxel, Doxorubicin, Pertuzumab, Trastuzumab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Cyclophosphamide, Doxorubicin, Paclitaxel, Pertuzumab, Trastuzumab