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Trastuzumab-biosimilar Herzuma® FDA approved in HER2+ breast cancer
By: News Feed | Last updated: 21st December 2018 | In: Breast Cancer, Oncology, Targeted Therapies, US FDA Onc\Haem Approvals
Article Keywords
breast cancer, Celltrion, FDA, Genentech, HER2-positive, Herceptin, Herzuma, Roche, trastuzumab
On 14 December 2018, the FDA approved the Herceptin®-biosimilar Herzuma® (trastuzumab-pkrb, Celltrion), a HER2/neu receptor antagonist, for patients with HER2-overexpressing (HER2+) breast cancer. Herzuma® was approved as biosimilar, not as an interchangeable product.
Data
The Herzuma® approval was based on comparisons of:
- Extensive structural characterisation;
- Functional product characterisation;
- Animal data;
- Human pharmacokinetics;
- Clinical immunogenicity;
- Other clinical data demonstrating that Herzuma® is biosimilar to United States Herceptin® (Genentech / Roche).
Safety
Common adverse events (AEs) of Herzuma® observed in patients with HER2+ breast cancer include: headache, diarrhoea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough, and rash. Serious expected AEs of Herzuma® include worsening of chemotherapy-induced neutropenia.
Similar to Herceptin®, the Herzuma®-label includes a ‘Boxed Warning’ to alert healthcare professionals and patients about the increased risks of cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-foetal toxicity.
Disclaimer
This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).
© Copyright 2018 MediPaper Medical Communications Ltd.
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