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04-12-2017 | Oncology | News | Article

approvalsWatch

FDA approves trastuzumab biosimilar

medwireNews: The first biosimilar formulation of trastuzumab has received FDA approval for the treatment of patients with breast cancer or metastatic gastric and gastro-esophageal junction tumours.

Trastuzumab-dkst may be used in US patients whose disease has been shown to overexpress the HER2 gene but is not considered to be an interchangeable product with the branded formulation of trastuzumab.

Common adverse events in breast cancer patients include headache, gastrointestinal side effects, fever, infection, and congestive heart failure, while patients with metastatic gastric cancer may experience neutropenia, gastrointestinal events, anemia, stomatitis, fever, and infection.

As per the branded agent, trastuzumab-dkst carries a Boxed Warning for cardiomyopathy, pulmonary toxicity, infusion reactions and embryo–fetal toxicity.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2017 Springer Healthcare part of the Springer Nature group

See also:

·         Bevacizumab biosimilar approved in USA

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