Japanese pharma major Chugai (TYO: 4519) has filed an application with the Japanese Ministry of Health, Labor and Welfare (MHLW) for the approval of anti-HER2 humanized monoclonal antibody, Perjeta Infusion (pertuzumab) for the additional indication of adjuvant therapy for HER2-positive early breast cancer. Perjeta was first launched in Japan in the fall of 2013.
"Currently, adjuvant chemotherapy with Herceptin(trastuzumab for HER2-positive early breast cancer has been recommended in the clinical practice guidelines for breast cancer and has contributed to patients," said Dr Yasushi Ito, Chugai’s senior vice president, head of project and lifecycle management unit. "We are going to continue discussions with the health authorities so that adjuvant chemotherapy using Perjeta in combination with Herceptin, which has outperformed the current standard of care, will be used as a new treatment option for patients," he added.
Clinical backing
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