Phesgo FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 27, 2021.
FDA Approved: Yes (First approved June 29, 2020)
Brand name: Phesgo
Generic name: pertuzumab, trastuzumab, and hyaluronidase-zzxf
Dosage form: Injection
Company: Genentech, Inc.
Treatment for: Breast Cancer
Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) is a combination of two HER2/neu receptor antagonists and the endoglycosidase hyaluronidase indicated for the treatment of early and metastatic HER2-positive breast cancer, as detected by an FDA-approved companion diagnostic test.
- Early Breast Cancer (EBC)
Phesgo is indicated for use in combination with intravenous chemotherapy as:
- neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer 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.
- Metastatic Breast Cancer (MBC)
Phesgo is indicated for use in combination with intravenous docetaxel as:
- treatment of patients with HER2- positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
- The Phesgo product label carries a boxed warning advising advising health care professionals and patients of the potential risks of cardiomyopathy, embryo-fetal toxicity, and pulmonary toxicity.
- Phesgo is initially used in combination with chemotherapy. Phesgo can be administered subcutaneously into the thigh by a health professional at home once the chemotherapy regimen is finished.
- Common side effects include alopecia, nausea, diarrhea, anemia, and asthenia.
Development timeline for Phesgo
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.