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FDA approves Herzuma, biosimilar to Herceptin, for breast cancer subset
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The FDA today approved trastuzumab-pkrb for the treatment of patients with HER2-positive breast cancer, the agency announced in a press release.
Trastuzumab-pkrb (Herzuma, Celltrion) — a biosimilar to trastuzumab (Herceptin, Genentech) — is a HER2/neu receptor antagonist.
Common adverse events associated with 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.
The label for trastuzumab-pkrb — like the label for its reference product — includes a boxed warning to alert health care providers and patients about elevated risks for cardiomyopathy, infusion reactions, pulmonary toxicity and embryo-fetal toxicity.