Daiichi Sankyo has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for ENHERTU (trastuzumab deruxtecan), a treatment for adult patients with HER2 low (IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy.
ENHERTU, which is a HER2 directed ADC, features a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload through a stable tetrapeptide-based cleavable linker.
The approval of ENHERTU has made it the first HER2 directed therapy for patients with the condition.
The company has received approval for the therapy based on the data from the DESTINY-Breast04 phase 3 study.
According to the press statement, ENHERTU significantly lowers the risk of disease progression or death by 50% as compared to the physician’s choice of chemotherapy in the DESTINY-Breast04 trial.
Last year, Daiichi Sankyo received priority review status for ENHERTU from MHLW for this tumour type based on trial data.
Daiichi Sankyo Japan R&D division head and executive officer Dr Wataru Takasaki said: “For the first time, certain patients in Japan whose tumours have a low HER2 expression have a treatment option available targeted specifically for them”.
“This is the third indication approved within three years in Japan for ENHERTU for patients with breast cancer and this medicine has the potential to become standard of care for patients with low HER2 expression”, he added.
ENHERTU is already approved in over 40 countries to treat adult patients with HER2 low metastatic breast cancer.