Daiichi Sankyo ENHERTU gets Japanese nod for patients with previously treated HER2 Positive Metastatic Breast Cancer
ENHERTU (trastuzumab deruxtecan, fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC.;
Tokyo: Daiichi Sankyo has announced that ENHERTU (trastuzumab deruxtecan) has been approved in Japan for the treatment of adult patients with HER2-positive unresectable or recurrent breast cancer after prior chemotherapy, which includes trastuzumab and a taxane.
ENHERTU (trastuzumab deruxtecan, fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC.
The approval by Japan's Ministry of Health, Labour and Welfare (MHLW) was based on the results of the DESTINY-Breast03 trial where ENHERTU demonstrated a 72% reduction in the risk of disease progression or death compared to trastuzumab emtansine (T-DM1) (hazard ratio [HR] = 0.28; 95% confidence interval [CI]: 0.22-0.37; p<0.000001) in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. The median progression-free survival (PFS) for patients treated with ENHERTU was not reached (95% CI: 18.5-NE) compared to 6.8 months for T-DM1 (95% CI: 5.6-8.2) as assessed by blinded independent central review (BICR). Data from DESTINY-Breast03 has met the requirement for a confirmatory phase 3 trial as part of the conditional early approval received in Japan in March 2020.
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