Trastuzumab-dkst (Ogivri)

Note: this is the second FDA-approved biosimilar. The information below is reproduced from the Trastuzumab (Herceptin) page, except for the details of FDA indication.

General information

Class/mechanism: HER2/neu receptor antagonist, humanized IgG1 kappa monoclonal antibody. Trastuzumab binds to the extracellular domain of HER2/erbB2 (human epidermal growth factor receptor 2), which is overexpressed in certain malignancies. Trastuzumab helps to mediate antibody-dependent cellular cytotoxicity (ADCC) preferentially against cells that overexpress HER2.
Route: IV
Extravasation: neutral

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

• HER2+ breast cancer
• HER2+ esophageal cancer
• HER2+ gastric cancer

Patient drug information

To be completed

History of changes in FDA indication

• 12/1/2017: Initial FDA approval for the treatment of patients with HER2-overexpressing|breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).