FDA clears subcutaneous injectable to treat breast cancer

March 18, 2019
Christine Blank

FDA approved a new subcutaneous injection to treat a certain type of early breast cancer.

The approval of trastuzumab and hyaluronidase-oysk (Herceptin Hylecta) was granted to Roche, the manufacturer of Herceptin, for certain people with HER2-positive early breast cancer (node-positive, or node-negative and ER/PR-negative or with 1 high-risk feature) in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with paclitaxel or alone in people who have received 1 or more chemotherapy regimens for metastatic disease.

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Herceptin Hylecta is a ready-to-use formulation that can be administered in 2 to 5 minutes, compared to 30 to 90 minutes for intravenous Herceptin. The new treatment includes the same monoclonal antibody as intravenous Herceptin, in combination with recombinant human hyaluronidase PH20, an enzyme that helps to deliver trastuzumab under the skin, Roche said in a statement.

“Over the past 20 years, Herceptin has significantly advanced treatment of HER2-positive breast cancer,” said Sandra Horning, MD, chief medical officer and head of global product development at Roche, in the statement. “The approval of Herceptin Hylecta gives physicians and patients in the US a new option to select treatment based on individual needs and preferences.”

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FDA’s approval is based on results from 3 clinical studies in HER2-positive early breast cancer, including the PrefHER patient preference study of adjuvant Herceptin Hylecta followed by intravenous Herceptin, or the reverse sequence. The majority (86%) of people preferred Herceptin Hylecta over IV Herceptin.

In addition, the phase 3 HannaH study compared neoadjuvant and adjuvant Herceptin Hylecta to IV Herceptin, both in combination with chemotherapy. Subcutaneous administration of Herceptin Hylecta resulted in non-inferior levels of trastuzumab in the blood (pharmacokinetics) and non-inferior clinical efficacy (pathological complete response rate; pCR) compared to intravenous Herceptin, Roche said.

The most common side effects in people receiving Herceptin Hylecta for early breast cancer were feeling tired, joint pain, diarrhea, injection-site reaction, upper respiratory tract infection, rash, muscle pain, nausea, headache, swelling, flushing, fever, cough, and pain in extremity.

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