Combination of | |
---|---|
Trastuzumab | HER2/neu receptor antagonist |
Hyaluronidase | Endoglycosidase |
Clinical data | |
Trade names | Herceptin SC, Herceptin Hylecta |
AHFS/ Drugs.com | Micromedex Detailed Consumer Information |
MedlinePlus | a619041 |
Routes of administration | Subcutaneous injection |
ATC code |
|
Legal status | |
Legal status | |
Identifiers | |
CAS Number | |
UNII | |
KEGG |
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. [1] [2] [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. [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]
Combination of | |
---|---|
Trastuzumab | HER2/neu receptor antagonist |
Hyaluronidase | Endoglycosidase |
Clinical data | |
Trade names | Herceptin SC, Herceptin Hylecta |
AHFS/ Drugs.com | Micromedex Detailed Consumer Information |
MedlinePlus | a619041 |
Routes of administration | Subcutaneous injection |
ATC code |
|
Legal status | |
Legal status | |
Identifiers | |
CAS Number | |
UNII | |
KEGG |
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. [1] [2] [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. [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]