FDA Approves New Combo Breast Cancer Treatment for Subcutaneous Injection

Officials with the FDA have approved a new combination treatment for subcutaneous injection to treat adult patients with metastatic HER2-positive breast cancer and early HER2-positive breast cancer in combination with intravenous (IV) chemotherapy, according to a press release.¹

The fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase-zzxf injection (Phesgo; Genentech) contains the same therapeutic components as those in FDA-approved IV pertuzumab and IV trastuzumab. It is available in 1 single-dose vial. The treatment can be administered by a health care professional in a treatment center or at a patient’s home.¹

Approval of the new combination therapy is based on results of a non-inferiority clinical study, the phase 3 FeDeriCa study, which included patients with HER2-positive early breast cancer. According to the data, pertuzumab and trastuzumab with hyaluronidase-zzxf demonstrated comparable efficacy and safety as IV pertuzumab and IV trastuzumab. However, administration-related reactions were higher with the combination injection due to the subcutaneous route of administration.^1,2

Additionally, the phase 2 PHranceSCa study showed that 85% of patients receiving treatment for HER2-positive breast cancer preferred treatment under the skin to IV administration due to less time in the clinic and more comfortable treatment administration.²

The most common adverse effects in patients who received pertuzumab and trastuzumab with hyaluronidase-zzxf subcutaneous injection were alopecia, nausea, diarrhea, anemia, and asthenia. Worsening of chemotherapy-induced neutropenia may also occur.^1,2

According to Genentech, administration can take approximately 8 minutes for the initial loading dose and approximately 5 minutes for each subsequent maintenance dose. This is compared with approximately 150 minutes for infusion of a loading dose for pertuzumab and trastuzumab using the standard IV formulations, and between 60 to 150 minutes for subsequent maintenance infusions.²

“The FDA approval of Phesgo reflects our commitment to improving outcomes for the many people living with HER2-positive breast cancer,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, Genentech, said in a statement.² “Phesgo offers a treatment administration that supports the needs and preferences of individuals patients, and helps to meet the increasing demand across the health care system for faster and more flexible treatment options.”

References

1. FDA Approves Breast Cancer Treatment That Can Be Administered At Home By Health Care Professional. News Release. FDA; June 29, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-breast-cancer-treatment-can-be-administered-home-health-care-professional?utm_campaign=062929_PR_FDA%20Approves%20Breast%20Cancer%20Treatment%20That%20Can%20Be%20Administered%20At%20Home&utm_medium=email&utm_source=Eloqua

2. FDA Approves Genentech’s Phesgo (Fixed-Dose Combination of Perjeta and Herceptin for Subcutaneous Injection) for HER2-Positive Breast Cancer. News Release. Genentech; June 29, 2020. https://www.gene.com/media/press-releases/14859/2020-06-29/fda-approves-genentechs-phesgo-fixed-dos