Trazimera FDA Approval History
Reviewed by J.Stewart BPharm. Last updated on March 11, 2019.
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.
- 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, 2019||ApprovalFDA Approves Trazimera (trastuzumab-qyyp), a Biosimilar to Herceptin|
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