September 17, 2021

FDA Approves Subcutaneous Herceptin Combo for Breast Cancer

By Jennifer Barrett, Associate Editor
Published Online: Friday, Mar 01, 2019

Officials with the FDA have approved trastuzumab and hyaluronidase-oysk (Herceptin Hylecta, Genentech) subcutaneous injection for certain patients with HER2-positive early and metastatic breast cancer, according to a press release.

Trastuzumab and hyaluronidase-oysk is indicated for patients with early disease in combination with chemotherapy, and metastatic disease in combination with paclitaxel, or alone in patients who have received 1 or more chemotherapy regimens.

This subcutaneous treatment includes the same monoclonal antibody as intravenous trastuzumab in combination with recombinant human hyaluronidase PH20, an enzyme that helps to deliver trastuzumab under the skin, according to Genentech. Trastuzumab and hyaluronidase-oysk is a ready-to-use formulation that can be administered in 2 to 5 minutes.

The approval is based on data from 3 clinical trials in HER2-positive early breast cancer: HannaH, SafeHER, and PrefHER.

In the HannaH study, both neoadjuvant and adjuvant subcutaneous trastuzumab and hyaluronidase-oysk treatments were compared with intravenous trastuzumab, both in combination with chemotherapy. Patients administered with subcutaneous trastuzumab and hyaluronidase-oysk demonstrated noninferior levels of trastuzumab in the blood and noninferior clinical efficacy compared with intravenous trastuzumab.

The SafeHER study evaluated adjuvant trastuzumab and hyaluronidase-oysk and found no new safety signals, according to the data. Additionally, in the PrefHER patient reference study, 86% of patients preferred subcutaneous trastuzumab and hyaluronidase-oysk over intravenous trastuzumab.

The most common adverse effects reported in the trials were fatigue, joint pain, diarrhea, injection site reaction, upper respiratory tract infection, rash, muscle pain, headache, swelling, flushing, fever, cough, and pain in extremity.

“Over the past 20 years, Herceptin has significantly advanced treatment of HER2-positive breast cancer,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a prepared statement. “The approval of Herceptin Hylecta gives physicians and patients in the United States a new option to select treatment based on individual needs and preferences.”


FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers [news release]. Genentech. Accessed February 28, 2019.

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