New Trastuzumab Biosimilar Approved by the FDA
Posted: Monday, June 17, 2019
On June 14, 2019, the U.S. Food and Drug Administration (FDA) approved trastuzumab-anns (Kanjinti) for all approved indications of the reference product trastuzumab (Herceptin) in the treatment of HER2-overexpressing adjuvant and metastatic breast cancers.
Trastuzumab-anns is a biosimilar to trastuzumab, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody. The active ingredient of trastuzumab-anns is a humanized monoclonal antibody that has the same amino acid sequence, structure, and function as trastuzumab. Trastuzumab-anns has the same pharmaceutical dosage form and same strength after reconstitution as trastuzumab.
Trastuzumab-anns has proved to be highly similar to and to have no clinically meaningful differences from trastuzumab, based on a comprehensive totality of evidence that included extensive comparative analytic, pharmacokinetic, and clinical data. At the time of approval, trastuzumab-anns is the only trastuzumab biosimilar to incorporate the evaluation of a single transition in the clinical study, demonstrating similar safety and immunogenicity in patients who were previously treated with trastuzumab.
In the United States, trastuzumab-anns is approved for the adjuvant treatment of HER2-overexpressing node-positive or node-negative breast cancer as part of a treatment regimen containing doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; with docetaxel and carboplatin; or as a single agent after multimodality anthracycline-based therapy. Patients should be selected for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
Trastuzumab-anns is also indicated for metastatic breast cancer in combination with paclitaxel in the 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.