Chugai Pharma Herceptin gets Japanese nod for additional indication of salivary gland cancer
Tokyo: Chugai Pharmaceutical Co., Ltd. has announced that the company has obtained approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the anti-HER2 humanized monoclonal antibody Herceptin Injection 60 and 150 [generic name: 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'd like to thank everyone who strongly supported us toward the approval based on evidence from Japan, particularly those involved in the investigator-initiated clinical trial that formed the basis for approval," said Chugai's President and CEO, Dr. Osamu Okuda. "Herceptin has been used as a standard treatment for breast and gastric cancer for many years. We are committed to promoting appropriate use of Herceptin so that it can contribute to the treatment of salivary gland cancer, a cancer with high unmet needs."
The approval is based on a Japanese investigator-initiated phase II clinical study (HUON-003-01 study) with 16 patients with HER2-positive advanced or recurrent salivary gland cancer. The study investigated the efficacy and safety of Herceptin in combination with docetaxel. The primary endpoint was the response rate. 60% of 15 patients in the efficacy analysis population showed response (95%Cl: 32.3 - 83.7).
HER2 protein overexpression and gene amplification should be determined with the pathological testing kit VENTANA ultraView Pathway HER2 (4B5) and VENTANA DISH HER2, both provided by Roche Diagnostics K.K. obtained regulatory approval for the two tests on November 11, 2021 as companion diagnostics for Herceptin to identify advanced or recurrent HER2-positive salivary gland cancer not amenable to curative resection.
