FDA Approves Trastuzumab-pkrb for HER2-Overexpressing Breast Cancer
On December 14, the U.S. Food and Drug Administration (FDA) approved trastuzumab-pkrb (Herzuma), a HER2/neu receptor antagonist biosimilar to trastuzumab (Herceptin), for the following indications:
- Adjuvant breast cancer of HER2 overexpressing node-positive or node-negative (estrogen receptor/progesterone receptor–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.
Standards for Biosimilar Approval
Trastuzumab-pkrb meets the FDA’s rigorous standards as a biosimilar to the reference product for the approved indications based on a totality of evidence. 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 trastuzumab-pkrb demonstrated that there were no clinically meaningful differences in purity, potency, and safety between trastuzumab-pkrb and trastuzumab 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 embryofetal toxicity. Please see the full Boxed Warning, additional important safety information, and accompanying prescribing information.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
