FDA accepts subcutaneous combination of pertuzumab and trastuzumab for HER2+ breast cancer

Breast cancer is the most common type of malignancy in women.1 Human epidermal growth factor receptor 2 (HER2) positive breast cancer accounts for 20–25% of breast cancers worldwide and is of great concern in research and clinical practice.2

Recent decades have seen exceptional progress in the regimens developed for the treatment of HER2-positive breast cancer. The intravenous (IV) formulation of trastuzumab and pertuzumab, two humanized IgG1 monoclonal antibodies, in combination with chemotherapy, has been approved for the treatment of both early and metastatic HER2-positive breast cancer.3,4

Recently, the first subcutaneous (SC) fixed-dose combination of pertuzumab, trastuzumab and chemotherapy was evaluated in the phase III FeDeriCa study (NCT03493854). SC administration of the fixed-dose combination demonstrated non-inferior serum trough concentration (Ctrough) of pertuzumab during cycle 7 (pre-dose cycle 8) when compared to IV administration, which was the primary endpoint of the trial. A secondary endpoint of non-inferior trastuzumab levels in the blood after SC administration was also met.5,6 Additionally, the safety profile appeared identical between the two treatment regimens, and no new safety concerns were identified.6

Supported by this result, a Biologics License Application (BLA) for the fixed-dose SC formulation of pertuzumab and trastuzumab with hyaluronidase in combination with IV chemotherapy has been accepted by the Food Drug and Administration (FDA) for the treatment of eligible patients with HER2-positive breast cancer.5

The SC fixed-dose combination significantly reduces the time spent receiving treatment, as the administration takes approximately 8 minutes for the loading dose and around 5 minutes for the maintenance doses. In comparison, the current treatment given intravenously can take up to 150 minutes for infusion of a loading dose and between 60-150 for the maintenance infusions of the two medicines.5

Pertuzumab and trastuzumab SC administration offers patients a more convenient administration route and can potentially improve quality of life due to the short administration time. The FDA is expected to decide on the approval of the therapy by 18 October 2020.

Written by Marta Palhas

Edited by Tom Southgate and Esther Drain


  1. World Cancer Research Fund. Breast cancer statistics (2018). Available: https://www.wcrf.org/dietandcancer/cancer-trends/breast-cancer-statistics. Last accessed 02/03/2020.
  2. Wang J, Xu B. Targeted therapeutic options and future perspectives for HER2-positive breast cancer. Signal Transduct Target Ther. 2019 Sep 13;4:34.
  3. European Medicines Agency. Summary of Product Characteristics for Herceptin (2019). Available: https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf. Last accessed 28/02/2020.
  4. European Medicines Agency. Summary of Product Characteristics for Perjeta (2019). Available: https://www.ema.europa.eu/en/documents/product-information/perjeta-epar-product-information_en.pdf. Last accessed 28/02/2020.
  5. Roche. FDA accepts Roche’s Biologics License Application for fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer (2020). Available: https://www.roche.com/media/releases/med-cor-2020-02-25.htm. Last accessed 02/03/2020.
  6. Tan A, et al. Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive early breast cancer: primary analysis of the phase III, multicenter, randomized, open-label, two-arm FeDeriCa study. Presented at SABCS, 2019 Dec 10-14; San Antonio, Texas. Abstract #PD4-07.