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Trastuzumab-biosimilar Ontruzant® FDA approved in several indications
By: News Feed | Last updated: 21st January 2019 | In: Breast Cancer, Gastrointestinal Cancer, Oncology, Targeted Therapies, US FDA Onc\Haem Approvals
biosimilar, breast cancer, FDA, Genentech, HER2-positive, Herceptin, Merck, Ontruzant, Roche, Samsung BioEpis, trastuzumab
On 18 January 2019, the FDA approved the Herceptin®-biosimilar Ontruzant® (trastuzumab-dttb, Samsung BioEpis), a HER2/neu receptor antagonist, for patients with HER2-overexpressing (HER2+) breast cancer in the adjuvant and metastatic setting, and in metastatic HER2+ gastric cancer patients. Ontruzant® was approved as biosimilar, not as an interchangeable product.
Common AEs of Ontruzant® observed in ≥ 10% patients with HER2+ metastatic gastric cancer include neutropenia, diarrhoea, fatigue, anaemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.
Similar to Herceptin®, the Ontruzant®-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.
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).
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