FDA Approves Trastuzumab Biosimilar for Treatment of HER2-overexpressing Breast Cancer
The FDA has approved trastuzumab-pkrb (Herzuma, Celltrion) as a biosimilar to trastuzumab (Herceptin, Genentech).
The FDA has approved trastuzumab-pkrb (Herzuma, Celltrion) as a biosimilar to trastuzumab (Herceptin, Genentech). Trastuzumab-pkrb is a HER2/neu receptor antagonist indicated for the treatment of HER2-overexpressing breast cancer.
Common expected adverse effects of trastuzumab-pkrb include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough, and rash. Serious expected adverse effects of trastuzumab-pkrb include worsening of chemotherapy-induced neutropenia.
Like trastuzumab, the labeling for trastuzumab-pkrb contains a Boxed Warning to alert health care professionals and patients about increased risks of cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-fetal toxicity.
Reference
FDA, Division of Drug Information. FDA approves Herzuma (trastuzumab-pkrb), biosimilar to Herceptin (trastuzumab) [news release]. Silver Spring, MD; December 14, 2018: FDA website. www.pharmacytimes.com/link/239?rel=0. Accessed December 14, 2018.
This article was originally published on Specialty Pharmacy Times® as "FDA Approves Herceptin Biosimilar Treatment of HER2-overexpressing Breast Cancer."
Nurse Practitioners Weigh in on Data From the San Antonio Breast Cancer Symposium
January 16th 2023Loyda Braithwaite, MSN, RN, AGPCNP-BC, AOCNP; and Jamie Carroll, APRN, CNP, MSN, highlight presentations from the 2022 San Antonio Breast Cancer Symposium that will influence oncology nursing practice.
FDA Approves Adjuvant Ribociclib Plus AI Therapy for HR+, HER2- Breast Cancer
September 17th 2024The Food and Drug Administration approved ribociclib plus an aromatase inhibitor for hormone receptor (HR)–positive, HER2-negative stage II and III early breast cancer that has a high risk of recurrence.
