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FDA Approves New Trastuzumab Biosimilar

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Today, 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.

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®.


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