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FDA approves subcutaneous Herceptin Hylecta for HER2-positive breast cancer
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The FDA approved trastuzumab and hyaluronidase-oysk for subcutaneous injection in certain patients with HER2-positive breast cancer.
This indication of trastuzumab and hyaluronidase-oysk (Herceptin Hylecta, Genentech) includes use for HER2-positive early breast cancer in combination with chemotherapy, and HER2-positive metastatic breast cancer in combination with paclitaxel or alone for patients who received one or more chemotherapy regimens for metastatic disease.
Trastuzumab and hyaluronidase-oysk includes the same monoclonal antibody as IV trastuzumab in combination with recombinant human hyaluronidase PH20, an enzyme used to deliver trastuzumab subcutaneously using Halozyme Therapeutics’ Enhanze drug delivery technology.
Whereas IV trastuzumab takes 30 to 90 minutes to administer, this ready-to-use formulation can be administered to 2 to 5 minutes.
“Over the past 20 years, Herceptin has significantly advanced treatment of HER2-positive breast cancer,” Sandra Horning, MD, Roche’s chief medical officer and head of global product development, said in a press release. “The approval of Herceptin Hylecta gives physicians and patients in the United States a new option to select treatment based on individual needs and preferences.”
Three clinical studies in HER2-positive early breast cancer supported this approval.
In the phase 3 HannaH study, neoadjuvant and adjuvant subcutaneous trastuzumab and hyaluronidase-oysk demonstrated comparable pharmacokinetics and noninferior pathologic complete response rate compared with IV trastuzumab.
Trastuzumab and hyaluronidase-oysk demonstrated safety and tolerability consistent with the known safety profile of IV trastuzumab in the phase 3 SafeHER study.
Further, 86% of patients preferred trastuzumab and hyaluronidase-oysk over IV trastuzumab in the PrefHER study.
The most common adverse events associated with trastuzumab and hyaluronidase-oysk for early breast cancer included fatigue, joint pain, diarrhea, injection site reaction, upper respiratory tract infection, rash, muscle pain, nausea, headache, swelling, flushing, fever, cough and extremity pain.