Chugai Pharmaceutical Co., Ltd. announced that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for the anti-HER2 humanized monoclonal antibody Herceptin injection 60 and 150 (trastuzumab) for the additional indication of advanced or recurrent HER2-positive salivary gland cancer not amenable to curative resection. Orphan drug designation had been granted by the MHLW on March 11, 2021 for this indication.
Salivary gland cancer, a type of head and neck cancer, is a rare cancer with less than 1,000 patients newly diagnosed annually in Japan. The standard therapy is primarily surgery, and there is no established chemotherapy for this cancer. Unlike other head and neck cancers, salivary gland cancer includes many histological types, associated with diversity in genomic alterations and prognosis. Less than 15% of all salivary cancers in Japan are estimated to be HER2-positive, relatively more common in salivary duct carcinomas.
"We are very pleased that Herceptin has become a new treatment option as the first personalized medicine for salivary gland cancer, for which no standard chemotherapy has been established so far. I
