2019-03-04| Trials & Approvals

Herceptin Hylecta bags FDA approval for HER2-Positive Breast Cancer Treatment

by Rajaneesh K. Gopinath
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By Rajaneesh K. Gopinath, Ph.D.

This new formulation is ready-to-use and can be administered as a subcutaneous injection within two to five minutes, as opposed to its intravenous counterpart that takes 30-90 minutes.

Herceptin (Trastuzumab) is a monoclonal antibody used for the treatment of breast cancer in patients overexpressing the Human Epidermal growth factor Receptor 2 (HER2), which belongs to the family of four epidermal growth factor receptors. These tyrosine kinases are found to be upregulated in various types of cancers including breast cancer and aids in the growth and survival of tumors. Herceptin selectively binds to the HER2 receptor and prevents dimerization, thereby resulting in cell cycle arrest. Initially available only as an intravenous (IV) injection, trastuzumab effectively increased the survival rates of metastatic breast cancer patients when given in combination with chemotherapy agents such as paclitaxel. In recent years though, a new subcutaneous formulation became increasingly popular due to the ease of administration. Initially approved in Europe in the year 2013, it is now approved in as many as 100 countries.


USFDA Approval

At this juncture, on the 28th of February, the USFDA approved trastuzumab and hyaluronidase-oysk injection, for subcutaneous use in certain patients with HER2-positive breast cancer. This formulation uses the same monoclonal antibody as that of IV trastuzumab. The antibody is delivered subcutaneously with the help of an enzyme, the recombinant human hyaluronidase PH20 using the Enhanze drug delivery technology developed by Halozyme Therapeutics.

The approval is based on the encouraging results obtained from three clinical studies in HER2-positive early breast cancer patients;

  • The phase III HannaH study (NCT00950300)
  • The phase III SafeHER study (NCT01566721) and
  • The PrefHER trial (NCT01401166)

“Over the past 20 years, Herceptin has significantly advanced treatment of HER2-positive breast cancer,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “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.”

IV trustuzumab is commonly known to cause adverse effects in patients. Likewise, the patients receiving Herceptin Hylecta reported to have experienced tiredness, joint pain, diarrhea, injection site reaction, upper respiratory tract infection, rash, muscle pain, nausea, headache, swelling, flushing, fever, cough, and extremity pain. The recommended dose is 600 mg trastuzumab and 10,000 units hyaluronidase administered subcutaneously once every three weeks.




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