Posted by Michael Wonder on 15 Dec 2018
Celltrion and Teva announce FDA approval of Herzuma (trastuzumab-pkrb), a biosimilar to Herceptin, for the treatment of HER2-over-expressing breast cancer for certain indications
15 December 2018 - Celltrion and Teva Pharmaceutical Industries today announced that the U.S. FDA has approved Herzuma (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to Herceptin (trastuzumab) for the following indications:
1. Adjuvant breast cancer of HER2 over-expressing 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
2. Metastatic breast cancer
- in combination with paclitaxel for first-line treatment of HER2-over-expressing metastatic breast cancer
- as a single agent for treatment of HER2-over-expressing 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.
