Daiichi Sankyo announced that it has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for trastuzumab deruxtecan, a HER2 directed antibody drug conjugate (ADC), for the treatment of adult patients with HER2 positive unresectable or recurrent breast cancer previously treated with trastuzumab and a taxane.

Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide, resulting in nearly 685,000 deaths globally. In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2020.

Approximately one in five cases of breast cancer are considered HER2 positive. Despite initial treatment with trastuzumab and a taxane, patients with HER2 positive metastatic breast cancer will often experience disease progression. More treatment options are needed to further delay progression and extend survival.

“There is a continued need in Japan for new therapeutic options for patients with HER2 positive metastatic breast cancer who often experience disease progression after initial treatment with available standards of care,” said Wataru Takasaki, PhD, Executive Officer, Head of R&D Division in Japan, Daiichi Sankyo. “We look forward to working with the Japan MHLW on this submission, as it marks a significant step towards bringing this important medicine to an earlier use in the metastatic setting for patients with HER2 positive breast cancer.”