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FDA Actions & Updates

The latest approvals, designations, and new indications from the U.S. Food and Drug Administration for oncology drugs.

Monday, June 17, 2019

FDA Approves Trastuzumab-Anns, a Biosimilar to Trastuzumab

The FDA has approved trastuzumab-anns for all approved indications of trastuzumab for the treatment of HER2-overexpressing adjuvant and metastatic 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 analytical, 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 the biosimilar is a humanized monoclonal antibody that has the same amino acid sequence, structure, and function as trastuzumab. It also has the same pharmaceutical dosage form and same strength after reconstitution as trastuzumab.

In the U.S., trastuzumab-anns is approved for the following:

Adjuvant Breast Cancer

Trastuzumab-anns is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:

  • As part of a treatment regimen containing doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
  • With docetaxel and carboplatin
  • As a single agent following multi-modality anthracycline-based therapy

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product

* High-risk is defined as ER/PR positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.

Metastatic Breast Cancer

Trastuzumab-anns is indicated:

  • In combination with paclitaxel for the 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

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product

Metastatic Gastric Cancer

Trastuzumab-anns is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.