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DECEMBER 17, 2018

FDA Approves Herzuma for Breast Cancer

The FDA approved trastuzumab-pkrb (Herzuma, Celltrion/Teva), a HER2/neu receptor antagonist biosimilar to trastuzumab (Herceptin, Genentech) for breast cancer treatment.

The new biosimilar is indicated: 

  • for adjuvant breast cancer of HER2 overexpressing node-positive or -negative (estrogen/progesterone-negative or with one high-risk feature) breast cancer;
  • as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; 
  • as part of a