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FDA Approves Biosimilar Trastuzumab-dttb

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On January 18, the U.S. Food and Drug Administration (FDA) approved trastuzumab-dttb (Ontruzant), a biosimilar referencing trastuzumab, across all eligible indications—namely, adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease.

The third trastuzumab biosimilar to be approved by the FDA, trastuzumab-dttb was also approved by the European Commission in November 2017 and has since been launched in a growing number of European countries.

More About Trastuzumab-dttb

Trastuzumab-dttb is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative breast cancer (estrogen receptor[ER]-negative/progesterone receptor [PR]-negative or with one high-risk feature [defined as ER/PR–positive with one of the following features: tumor size > 2 cm, age < 35 years, or tumor grade 2 or 3]) in the following settings:

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

Trastuzumab-dttb is also 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
  • 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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