FDA Approves Combination of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf for HER2-Positive Breast Cancer
On June 29, 2020, the Food and Drug Administration approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf (PHESGO®, Genentech, Inc.) for subcutaneous injection for the following indications:
- 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;
- adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.
- Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.