Herceptin Hylecta

Trastuzumab/hyaluronidase, sold under the brand name Herceptin SC among others, is a fixed-dose combination medication for the treatment of HER2-overexpressing breast cancer in adults. It is a combination of trastuzumab and hyaluronidase.

The most common adverse reactions include fatigue, arthralgia, diarrhea, injection site reaction, upper respiratory tract infection, rash, myalgia, nausea, headache, edema, flushing, pyrexia, cough, and pain in extremity.

Trastuzumab/hyaluronidase was approved for medical use in the European Union in August 2013. Trastuzumab/hyaluronidase was approved for medical use in the United States in February 2019.

Medical uses

Trastuzumab/hyaluronidase is indicated for adjuvant treatment of adults with HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature; and it is indicated in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer.

History

Trastuzumab/hyaluronidase (Herceptin SC) was approved for medical use in the European Union in August 2013.

Trastuzumab/hyaluronidase (Herceptin Hylecta) was approved for medical use in the United States in February 2019.

Approval of trastuzumab/hyaluronidase was based on two randomized trials, HannaH (NCT00950300) and SafeHER (NCT01566721). In HannaH, 596 participants with HER2-positive operable or locally advanced breast cancer, including inflammatory breast cancer, were randomized to receive 8 cycles of either trastuzumab/hyaluronidase or intravenous trastuzumab concurrently with chemotherapy, followed by surgery and continued therapy with either trastuzumab/hyaluronidase or intravenous trastuzumab, for an additional 10 cycles. HannaH demonstrated comparability between trastuzumab/hyaluronidase and intravenous trastuzumab based on co-primary endpoints of pathologic complete response and pharmacokinetics. Pathological complete response (pCR) was observed in 118 participants (45.4%) on the trastuzumab/hyaluronidase arm and in 107 participants (40.7%) receiving intravenous trastuzumab (95% CI for difference in pCR: -4.0; 13.4).

SafeHER was a prospective, two-cohort, non-randomized, multinational, open-label trial assessing the overall safety and tolerability of trastuzumab/hyaluronidase with chemotherapy in 1,864 participants with HER2-positive breast cancer. Participants received a fixed dose of 600 mg trastuzumab/hyaluronidase every 3 weeks for 18 cycles. trastuzumab/hyaluronidase was initiated either sequentially with chemotherapy, concurrently with chemotherapy, or without adjuvant chemotherapy, or in combination with neoadjuvant chemotherapy followed by trastuzumab.

Further reading

• "Application for the addition of Herceptin (trastuzmab) on the WHO Model List of Essential Medicines" (PDF). F. Hoffmann-La Roche Ltd. 7 December 2018.

External links

• "Trastuzumab". Drug Information Portal. U.S. National Library of Medicine.
• "Hyaluronidase". Drug Information Portal. U.S. National Library of Medicine.
• "Trastuzumab and Hyaluronidase-oysk". National Cancer Institute. 14 March 2019.
• "Trastuzumab and Hyaluronidase-oysk". NCI Drug Dictionary. National Cancer Institute.
• Clinical trial number NCT00950300 for "A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer" at ClinicalTrials.gov
• Clinical trial number NCT01566721 for "A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer (SafeHER)" at ClinicalTrials.gov