Trastuzumab/hyaluronidase

Last updated

Trastuzumab/hyaluronidase
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
  • 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]

Contents

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. 1 2 3 4 5 6 7 8 9 10 11 12 13 "FDA approves new formulation of Herceptin for subcutaneous use". U.S. Food and Drug Administration (FDA) (Press release). 28 February 2019. Archived from the original on 28 September 2019. Retrieved 8 August 2020.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  2. 1 2 3 4 "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. 1 2 "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. 1 2 "Drug Approval Package: Herceptin Hylecta". U.S. Food and Drug Administration (FDA). 17 October 2019. Retrieved 8 August 2020.
  6. 1 2 "FDA approves Herceptin Hylecta for subcutaneous injection in certain HER2-positive breast cancers". Roche (Press release). 28 February 2019. Retrieved 8 August 2020.
  7. 1 2 "FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers". Genentech (Press release). 28 February 2019. Retrieved 8 August 2020.
  8. 1 2 "Halozyme Announces FDA Approval Of Herceptin Hylecta" (Press release). Halozyme Therapeutics. 28 February 2019. Retrieved 8 August 2020– via PR Newswire.

Further reading


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