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FDA Approves Subcutaneous Trastuzumab Formulation for HER2+ Breast Cancer

Gina Columbus @ginacolumbusonc
Published: Thursday, Feb 28, 2019

The FDA has approved subcutaneous use of trastuzumab (Herceptin) and hyaluronidase-oysk injection (Herceptin Hylecta) in combination with chemotherapy for the treatment of select patients with HER2-positive early breast cancer, in combination with paclitaxel in patients with metastatic HER2-positive breast cancer as a frontline treatment, and alone for patients with metastatic disease who have received at least 1 prior chemotherapy regimen.1,2

The FDA previously approved IV trastuzumab for the adjuvant treatment of patients with HER2-overexpressing, node-positive or node-negative breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; with docetaxel and carboplatin; and as a single agent following multi-modality anthracycline-based therapy. It is also indicated as a single agent for patients with HER2-overexpressing breast cancer who have received one or more chemotherapy regimens for metastatic disease, or in combination with paclitaxel as a first-line treatment for patients with HER2-overexpressing metastatic breast cancer.


  1. FDA Approves New Formulation of Herceptin for Subcutaneous Use. FDA. Published February 28, 2019. Accessed February 28, 2019.
  2. FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers. Genentech (Roche). Published February 28, 2019. Accessed February 28, 2019.

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