MHLW (Japan) approves Enhertu for the treatment of adult patients with HER2-low unresectable or recurrent breast cancer after prior chemotherapy.- Daiichi Sankyo
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of adult patients with HER2-low unresectable or recurrent breast cancer after prior chemotherapy.The indication is for patients with HER2-low disease defined as immunohistochemistry (IHC) 1+ or IHC 2+/in situ hybridization.
The regulatory decision was supported by data from the phase III DESTINY-Breast04 trial (NCT03734029), which showed that the antibody-drug conjugate (ADC) reduced the risk of progression or death by 50% compared with physician’s choice of chemotherapy in patients with hormone receptor–positive or –negative, HER2-low metastatic breast
Patients treated with trastuzumab deruxtecan experienced a median progression-free survival (PFS) of 9.9 months (95% CI, 9.0-11.3) compared with 5.1 months (95% CI, 4.2-6.8) for those given chemotherapy. Additionally, the ADC reduced the risk of death by 36% compared with chemotherapy (HR, 0.64; 95% CI, 0.49-0.84; P = .001).
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