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FDA Approves Trastuzumab and Hyaluronidase-oysk for Subcutaneous Injection in Certain HER2-Positive Breast Cancers

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On February 28, the U.S. Food and Drug Administration (FDA) approved trastuzumab and hyaluronidase-oysk (Herceptin Hylecta) for subcutaneous injection for the treatment of certain patients with HER2-positive early breast cancer (node-positive, or node-negative and estrogen receptor/progesterone receptor–negative, or with one high-risk feature) in combination with chemotherapy. The FDA also approved the treatment in patients with HER2-positive metastatic breast cancer in combination with paclitaxel, or alone in patients who have received one or more prior chemotherapy regimens for metastatic disease. 

This new treatment includes the same monoclonal antibody as intravenous trastuzumab in combination with recombinant human hyaluronidase PH20, an enzyme that helps to deliver trastuzumab subcutaneously. The trastuzumab and hyaluronidase-oysk combination is a ready-to-use formulation that can be administered in 2 to 5 minutes, compared to 30 to 90 minutes for intravenous trastuzumab. Patients should be selected for therapy with the combination based on an FDA-approved companion diagnostic for trastuzumab.

HannaH, SafeHER, and PrefHER

The FDA approval is based on results from three clinical studies in HER2-positive early breast cancer:

  • The phase III HannaH study compared neoadjuvant and adjuvant trastuzumab/hyaluronidase-oysk to intravenous trastuzumab, both in combination with chemotherapy. Subcutaneous administration of trastuzumab and hyaluronidase-oysk resulted in noninferior levels of trastuzumab in the blood and noninferior clinical efficacy compared to intravenous trastuzumab. The pathologic complete response rate was 45.4% with trastuzumab/hyaluronidase-oysk, compared to 40.7% with trastuzumab alone.
  • The phase III SafeHER study of adjuvant trastuzumab/hyaluronidase-oysk identified no new safety signals, with safety and tolerability consistent with the known safety profiles of intravenous trastuzumanb and trastuzumab/hyaluronidase-oysk.
  • The PrefHER patient preference study of adjuvant trastuzumab/hyaluronidase-oysk followed by intravenous trastuzumab, or the reverse sequence, found the majority (86%) of patients preferred trastuzumab/hyaluronidase-oysk over intravenous trastuzumab.

The most common side effects in people receiving trastuzumab/hyaluronidase-oysk for early breast cancer were fatigue, joint pain, diarrhea, injection site reaction, upper respiratory tract infection, rash, muscle pain, nausea, headache, swelling, flushing, fever, cough, and pain in an extremity.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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