Trastuzumab-biosimilar Ontruzant® FDA approved in several indications

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By: scienterrific | Last updated: 21 January 2019 | In: Breast Cancer, Gastrointestinal Cancer, US FDA Onc\Haem Approvals, Oncology, Targeted Therapies

Article Keywords

biosimilar, Herceptin, HER2-positive, breast cancer, Ontruzant, Samsung BioEpis, trastuzumab, Merck, Roche, FDA, Genentech

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.

Safety

Common adverse events (AEs) of Ontruzant® observed in ≥5% patients with HER2+ breast cancer in the adjuvant setting include headache, diarrhoea, nausea, and chills.

Common AEs of Ontruzant® observed in ≥10% patients with HER2+ metastatic breast cancer include fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash.

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.

Full prescribing information Ontruzant®

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).

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