Herceptin Hylecta treats HER2-positive breast cancer and only needs to be injected subcutaneously and only used once every three weeks

At present, medical scientists have developed many targeted drugs for the treatment of breast cancer, including palbociclib, neratinib, everolimus and trastuzumab, etc. Herceptin Hylecta, the latest compound drug developed and launched on February 27, 2019, is a new type of drug that can be injected subcutaneously. It is as convenient as insulin for diabetic patients and only needs to be taken once every three weeks.

The DA has approved trastuzumab and hyaluronidase-ysys injection (Herceptin Hylecta, Genentech Inc.) for subcutaneous injection to treat breast cancer. Herceptin Hylecta is a combination of trastuzumab (a HER2/neu receptor antagonist) and hyaluronidase (an endoglycosidase) and is used to treat HER2-overexpressing breast cancer.
The FDA approval is based on the results of three clinical studies in HER2-positive early breast cancer:

The phase III HannaH study compared neoadjuvant (preoperative) and adjuvant (postoperative) Herceptin Hylecta to intravenous Herceptin, both combined with chemotherapy. Subcutaneous injection of Herceptin Hylecta resulted in blood trastuzumab levels (pharmacokinetics) and clinical efficacy (pathological complete response rate; pCR) that were non-inferior to intravenous Herceptin.

The Phase III SafeHER study of adjuvant Herceptin Hylecta found no new safety signals. The safety and effectiveness of intravenous Herceptin and Herceptin Hylecta are consistent.

Herceptin is the preferred adjuvant for patients with PreffHER Hylecta, followed by intravenous Herceptin or the reverse sequence, found that most (86%) people preferred Herceptin Hylecta over intravenous Herceptin.

Indications:

1. Adjuvant treatment of breast cancer

HERCEPTIN HYLECTA is indicated for the adjuvant treatment of adults with HER2-overexpressing node-positive or node-negative (ER/PR negative or one high-risk feature) breast cancer

l as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and paclitaxel or docetaxel.

l As part of a docetaxel and carboplatin treatment regimen.

l As a single agent after multimodal anthracycline therapy.

2. Metastatic breast cancer

HERCEPTIN HYLECTA is indicated in adults:

• In combination with paclitaxel for the first-line treatment of HER2-overexpressing metastatic breast cancer

• As a single agent for the treatment of HER2-overexpressing breast cancer in patients with metastatic disease who are receiving one or more chemotherapy regimens.

Recommended dose: 600 mg/10,000 units (600 mg trastuzumab and 10,000 units hyaluronidase) (total 5ml) subcutaneously administered over 2-5 minutes once every three weeks.

HERCEPTIN HYLECTA has different dosage and administration guidelines than intravenous trastuzumab products. Do not inject intravenously. And HERCEPTIN HYLECTA cannot be used as a substitute for Ado-trastuzumab emtansine (trastuzumab-emtansine conjugate)