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Fixed-Dose Subcutaneous Pertuzumab Combo Shows Noninferiority in HER2+ Breast Cancer

Gina Columbus
Published: Friday, Sep 13, 2019

Sandra Horning, MD, chief medical officer and head of Global Product Development, Roche

Sandra Horning, MD

A fixed-dose subcutaneous injection of pertuzumab (Perjeta) and trastuzumab (Herceptin) with hyaluronidase in combination with intravenous (IV) chemotherapy demonstrated noninferior pharmacokinetics compared with the standard IV infusions of the regimen in patients with HER2-positive early breast cancer, meeting the primary endpoint of the phase III FeDeriCa trial (NCT03493854).1

The approval was based on findings from the HannaH (NCT00950300) and SafeHER (NCT01566721) studies, in which Herceptin Hylecta demonstrated comparable rates of efficacy and safety compared with the standard IV use of trastuzumab, as well as the PrefHER trial (NCT01401166), which suggested a patient preference for the subcutaneous regimen.


  1. Genentech’s Fixed Dose Subcutaneous Combination of Perjeta And Herceptin Showed Non-Inferiority When Compared to Intravenous Formulations for People With HER2-Positive Breast Cancer. Genentech. Published September 12, 2019. Accessed September 13, 2019.
  2. FDA Approves New Formulation of Herceptin for Subcutaneous Use. FDA. Published February 28, 2019. Accessed February 28, 2019.

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