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