| Type: | combo |
| Component1: | Trastuzumab |
| Class1: | HER2/neu receptor antagonist |
| Component2: | Hyaluronidase |
| Class2: | Endoglycosidase |
| Tradename: | Herceptin SC, Herceptin Hylecta |
| Routes Of Administration: | Subcutaneous injection |
| Atc Prefix: | None |
| Legal Au: | S4 |
| Legal Ca: | Rx-only |
| Legal Us: | Rx-only |
| Legal Eu: | Rx-only |
| Legal Status: | Rx-only |
| Cas Number: | 180288-69-1 |
| Cas Number2: | 757971-58-7 |
| Unii: | P188ANX8CK |
| Unii2: | 743QUY4VD8 |
| Kegg: | D11560 |
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.[1] [2] It is a combination of trastuzumab and hyaluronidase.[3]
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.[4] Trastuzumab/hyaluronidase was approved for medical use in the United States in February 2019.[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.
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.