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.[1][2]
Trastuzumab/hyaluronidase was approved for medical use in the European Union in August 2013.[4] Trastuzumab/hyaluronidase was approved for medical use in the United States in February 2019.[1][5][6][7][8]
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.[1][2]
Trastuzumab/hyaluronidase (Herceptin SC) was approved for medical use in the European Union in August 2013.[4]
Trastuzumab/hyaluronidase (Herceptin Hylecta) was approved for medical use in the United States in February 2019.[1][5][6][7][8]
Approval of trastuzumab/hyaluronidase was based on two randomized trials, HannaH (NCT00950300) and SafeHER (NCT01566721).[1] 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.[1] HannaH demonstrated comparability between trastuzumab/hyaluronidase and intravenous trastuzumab based on co-primary endpoints of pathologic complete response and pharmacokinetics.[1] 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).[1]
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.[1] Participants received a fixed dose of 600 mg trastuzumab/hyaluronidase every 3 weeks for 18 cycles.[1] trastuzumab/hyaluronidase was initiated either sequentially with chemotherapy, concurrently with chemotherapy, or without adjuvant chemotherapy, or in combination with neoadjuvant chemotherapy followed by trastuzumab.[1]
^Duco MR, Murdock JL, Reeves DJ (March 2020). "Trastuzumab/Hyaluronidase-oysk: A New Option for Patients With HER2-Positive Breast Cancer". The Annals of Pharmacotherapy. 54 (3): 254–261. doi:10.1177/1060028019877936. PMID31595774. S2CID203983669.
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
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