Herzuma FDA Approval History
Reviewed by J.Stewart BPharm. Last updated on Dec 19, 2018.
FDA Approved: Yes (First approved December 14, 2018)
Brand name: Herzuma
Generic name: trastuzumab-pkrb
Dosage form: for Injection
Company: Celltrion, Inc. and Teva Pharmaceutical Industries Ltd.
Treatment for: Breast Cancer
Herzuma (trastuzumab-pkrb) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer.
Indications and Usage
- Adjuvant Breast Cancer of 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
- 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.
- In these indications, patients should be selected for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
- Herzuma is administered as an intravenous (IV) infusion.
FDA approval of Herzuma was based on comprehensive data that demonstrated no clinically meaningful differences in purity, potency and safety between Herzuma and Herceptin for the treatment of HER2-overexpressing breast cancer.
- Adjuvant Breast Cancer - Most common adverse reactions (≥5%) were headache, diarrhea, nausea, and chills.
- Metastatic Breast Cancer - Most common adverse reactions (≥ 10%) were fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash.
Herzuma (trastuzumab-pkrb) is the second FDA-approved trastuzumab biosimilar, following approval for Ogivri (trastuzumab-dkst) in December 2017.
Development Timeline for Herzuma
|Dec 14, 2018||ApprovalFDA Approves Herzuma (trastuzumab-pkrb), a Biosimilar to Herceptin|
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