Celltrion and Teva announced that the Food and Drug Administration (FDA) has approved Herzuma (trastuzumab-pkrb) injection, a new biosimilar to Herceptin (trastuzumab; Genentech) for certain HER2-overexpressing breast cancer indications. Patients should be selected for treatment based on an FDA-approved companion diagnostic for a trastuzumab product.
Specifically, Herzuma is approved to treat:
- 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; or 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; or as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease
Headache, diarrhea, nausea, chills, fever, headache, infection, congestive heart failure, insomnia, cough, and rash were the most commonly reported adverse events. Herzuma, a HER2/neu receptor antagonist, carries a Boxed Warning describing cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity.
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.