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FDA Approves New Trastuzumab Biosimilar


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On June 14, the U.S. Food and Drug Administration (FDA) approved trastuzumab-anns (Kanjinti) for all approved indications of the reference product trastuzumab (Herceptin): for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Trastuzumab-anns was proven to be highly similar to and to have no clinically meaningful differences from trastuzumab, based on a comprehensive totality of evidence, which 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 on trastuzumab.

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.

Patients should be selected for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. In the United States, trastuzumab-anns is approved for the following indications.

Adjuvant Treatment of Breast Cancer: Trastuzumab-anns is indicated for adjuvant treatment of breast cancer that is HER2-overexpressing and node-positive or node-negative (estrogen/progesterone receptor–negative or with one high-risk feature, where high-risk is defined as estrogen/progesterone receptor–positive with one of the following features: tumor size > 2 cm, age < 35 years, or tumor grade 2 or 3). In this setting, the new biosimilar can be used as part of a treatment regimen containing doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; with docetaxel and carboplatin; and as a single agent following multimodality anthracycline-based therapy

Metastatic Breast Cancer: Trastuzumab-anns is indicated in combination with paclitaxel for the first-line treatment of HER2-overexpressing metastatic breast cancer, and as a single agent for the treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.

Metastatic Gastric Cancer: Trastuzumab-anns is indicated, in combination with cisplatin and capecitabine or fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease. 


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