Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. received U.S. Food and Drug Administration (FDA) approval for Herzuma (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to Genentech’s Herceptin (trastuzumab) for the following indications:
- 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
The FDA approval is based on a review of a comprehensive data package inclusive of foundational analytical similarity data, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy, and safety data. The results of the clinical development program for Herzuma demonstrated that there were no clinically meaningful differences in purity, potency, and safety between Herzuma and Herceptin for the treatment of HER2-overexpressing breast cancer for the approved indications.
Trastuzumab products have a Boxed Warning which states that treatment with trastuzumab may be associated with cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-fetal toxicity.
Celltrion and Teva entered into an exclusive partnership in October 2016 to commercialize Herzuma in the U.S. and Canada.
(Source: Teva Pharmaceutical Industries Ltd.)
Filed Under: Oncology