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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.

References

  1. FDA Approves New Formulation of Herceptin for Subcutaneous Use. FDA. Published February 28, 2019. https://bit.ly/2H7MN5s. Accessed February 28, 2019.
  2. FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers. Genentech (Roche). Published February 28, 2019. https://bit.ly/2GQPiKg. Accessed February 28, 2019.

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