FDA approves subcutaneous trastuzumab for HER2+ breast cancer

  • FDA

  • curated by Miriam Davis, PhD
  • Univadis Clinical Summaries
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Takeaway

  • The FDA has approved a subcutaneous formulation of trastuzumab that strikingly reduces administration time in human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
  • Subcutaneous trastuzumab consists of trastuzumab plus hyaluronidase, an enzyme used to hasten absorption. Administration takes 2-5 minutes, according to an FDA news release, instead of 30-90 minutes with intravenous (IV) trastuzumab, according to a Genentech news release.

Why this matters

  • Subcutaneous trastuzumab is a new, more efficient treatment option.
  • Prescribing information is here.

Key points

  • Subcutaneous trastuzumab carries the same indications as the IV formulation for adjuvant treatment of HER2+ breast cancer and metastatic breast cancer, but is not indicated for metastatic gastric cancer.
  • The recommended dose is 600 mg trastuzumab and 10,000 units hyaluronidase once every 3 weeks.
  • Approval of subcutaneous trastuzumab was based on 2 trials, HannaH and SafeHER.
    • HannaH (N=596) showed noninferior pharmacokinetics and pathologic complete response with subcutaneous vs IV trastuzumab. 
    • SafeHER (N=1864) was a nonrandomized trial assessing safety of a 600-mg fixed dose of subcutaneous trastuzumab. The most frequent adverse events (in ≥10% of patients) included fatigue, arthralgia, diarrhea, and injection site reaction, according to the FDA news release.

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