BRIEF—Herceptin approved for salivary gland cancer in Japan

Japanese drugmaker Chugai, which is majority-owned by Swiss giant Roche, says that it obtained approval from the Ministry of Health, Labor and Welfare (MHLW) for the anti-HER2 humanized monoclonal antibody Herceptin (trastuzumab) injection 60 and 150 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.