On 4 October 2024, Daiichi Sankyo announced that it has submitted a supplemental new drug application for Enhertu® (trastuzumab deruxtecan) to Japan’s Ministry of Health, Labour and Welfare. The application proposes use of Enhertu® in adult patients with HER2 low (IHC 1+ or IHC 2+/ISH-) or ultralow (IHC 0 with membrane staining) unresectable or recurrent breast cancer.
Enhertu® has previously been approved for HER2-low breast cancer in Japan (March 2023), as well as in China (July 2023) and the US (August 2022). In August 2023, Enhertu® was approved in Japan to treat patients with unresectable advanced or recurrent non-small cell lung cancer (NSCLC) with HER2 (ERBB2) mutations that has progressed after chemotherapy.