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Herzuma Approved for Treatment of Breast Cancer
The FDA has approved another biosimilar for the adjuvant treatment of HER2 overexpressing, node-positive or node-negative breast cancer. In addition, this biosimilar Herzuma (trastuzumab-pkrb, Celltrion, South Korea, and Teva Pharmaceutical, Israel) is approved as part of a first-line treatment for metastatic breast cancer combined with chemotherapy.
Common adverse events associated with the use of trastuzumab-pkrb for treatment of HER2-positive breast cancers include diarrhea, headache, chills, nausea, fever, infection, insomnia, congestive heart failure, cough and rash. Serious adverse effects can include worsening of chemotherapy-induced neutropenia.
Like its reference product trastuzumab (Herceptin, Genentech), trastuzumab-pkrb carries a boxed warning about elevated risks for cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-fetal toxicity.
Source: Biospace.com, December 17, 2018