Therapy Areas: Oncology
Enhertu Approved in the US for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen
11 May 2022 - - Japanese pharmaceutical company Daiichi Sankyo (TSX: 4568) and UK-based pharmaceutical company AstraZeneca's (LSE: AZN) (NASDAQ: AZN) Enhertu (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy, the companies said.

Enhertu is a specifically engineered HER2 directed antibody drug conjugate being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

The approval by the US Food and Drug Administration was based on positive results from the pivotal DESTINY-Breast03 phase 3 trial that showed Enhertu reduced the risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1) (hazard ratio [HR] = 0.28; 95% confidence interval [CI]: 0.22-0.37; p
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