Trastuzumab/hyaluronidase

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Trastuzumab/hyaluronidase
Combination of
TrastuzumabHER2/neu receptor antagonist
HyaluronidaseEndoglycosidase
Clinical data
Trade namesHerceptin SC, Herceptin Hylecta
AHFS/Drugs.comMicromedex Detailed Consumer Information
MedlinePlusa619041
Routes of
administration		Subcutaneous injection
ATC code
  • None
Legal status
Legal status
  • AU: S4 (Prescription only)
  • CA: ℞-only
  • US: ℞-only
  • EU: Rx-only
  • In general: ℞ (Prescription only)
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]

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.[1][2]

History

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]

References

  1. ^ a b c d e f g h i j k l m "FDA approves new formulation of Herceptin for subcutaneous use". U.S. Food and Drug Administration (FDA) (Press release). 28 February 2019. Retrieved 8 August 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  2. ^ a b c d "Herceptin Hylecta- trastuzumab and hyaluronidase-oysk injection, solution". DailyMed. 13 May 2019. Retrieved 8 August 2020.
  3. ^ 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. PMID 31595774. S2CID 203983669.
  4. ^ a b "Commercial Launch of Herceptin SC in EU Triggers Milestone Payment to Halozyme from Roche". Halozyme Therapeutics (Press release). 28 August 2013. Retrieved 8 August 2020.
  5. ^ a b "Drug Approval Package: Herceptin Hylecta". U.S. Food and Drug Administration (FDA). 17 October 2019. Retrieved 8 August 2020.
  6. ^ a b "FDA approves Herceptin Hylecta for subcutaneous injection in certain HER2-positive breast cancers". Roche (Press release). 28 February 2019. Retrieved 8 August 2020.
  7. ^ a b "FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers". Genentech (Press release). 28 February 2019. Retrieved 8 August 2020.
  8. ^ a b "Halozyme Announces FDA Approval Of Herceptin Hylecta" (Press release). Halozyme Therapeutics. 28 February 2019. Retrieved 8 August 2020 – via PR Newswire.

Further reading

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
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