Skip to main content

Trazimera FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 27, 2020.

FDA Approved: Yes (First approved March 11, 2019)
Brand name: Trazimera
Generic name: trastuzumab-qyyp
Dosage form: for Injection
Company: Pfizer Inc.
Treatment for: Breast Cancer, Gastric Cancer

Trazimera (trastuzumab-qyyp) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Indications and Usage

  • Adjuvant Breast Cancer HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer
    • as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
    • as part of a treatment regimen with docetaxel and carboplatin
    • as a single agent following multi-modality anthracycline based therapy.
  • Metastatic Breast Cancer
    • in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer
    • as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.
  • Metastatic Gastric Cancer in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
  • In these indications, patients should be selected for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
  • Trazimera is administered as an intravenous (IV) infusion.

Adverse Reactions

  • Adjuvant Breast Cancer - Most common adverse reactions (≥ 5%) are headache, diarrhea, nausea, and chills.
  • Metastatic Breast Cancer - Most common adverse reactions (≥ 10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash.
  • Metastatic Gastric Cancer - Most common adverse reactions (≥ 10%) are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.

Trazimera (trastuzumab-qyyp) is the fourth FDA-approved trastuzumab biosimilar, following the approvals for Ontruzant (trastuzumab-dttb) in January 2019, Herzuma (trastuzumab-pkrb) in December 2018, and Ogivri (trastuzumab-dkst) in December 2017.

Development Timeline for Trazimera

Mar 11, 2019Approval  FDA Approves Trazimera (trastuzumab-qyyp), a Biosimilar to Herceptin

Further information

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