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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

Jun 29, 2020Approval  FDA Approves Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) for HER2-Positive Breast Cancer
Feb 24, 2020FDA Accepts Genentech’s Biologics License Application for Fixed-Dose Subcutaneous Combination of Perjeta And Herceptin For HER2-Positive Breast Cancer

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.