Hylecta – pro
HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk) is approved for the treatment of adults with early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.* HERCEPTIN HYLECTA can be used in several different ways:
As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as “ACTH”
With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as “TCH”
Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin) based therapy (a type of chemotherapy)
Patients are selected for therapy based on an FDA-approved test for trastuzumab
HERCEPTIN HYLECTA in combination with the chemotherapy drug paclitaxel is approved for the first line treatment of Human Epidermal growth factor Receptor 2-positive (HER2+) metastatic breast cancer
HERCEPTIN HYLECTA alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic disease. Neither is changing for Herceptin to Hylecta studies or reproted.
The recommended dose of HERCEPTIN HYLECTA is 600 mg/10,000 units (600 mg trastuzumab and 10,000 units hyaluronidase) administered subcutaneously over approximately 2-5 minutes once every three weeks
Hylecta Prescribing Information 2021
Ismael G, Hegg R, Muehlbauer S, et al. Subcutaneous versus intravenous administration of
(neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH
study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol. 2012 Sep; 13(9): 869-78.
https://www.ncbi.nlm.nih.gov/pubmed/22884505
Gligorov J, Ataseven B, Verrill M, et al. Safety and tolerability of subcutaneous trastuzumab for
the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer:
SafeHer phase III study’s primary analysis of 2573 patients. Eur J Cancer. 2017 Sep; 82:237-246.
https://www.ncbi.nlm.nih.gov/pubmed/28625777
Pivot X, Gligorov J, Muller V, et al. Preference for subcutaneous or intravenous
administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an openlabel randomised study. Lancet Oncol. 2013 Sep;14(10):962-70.