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
Further information
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