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:
Trastuzumab-dttb is also indicated:
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®.