Therapy Areas
Trastuzumab Deruxtecan Recommended for Approval in the EU by CHMP for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen
29 June 2022 - - Japan-based pharmaceutical company Daiichi Sankyo (TSX: 4568) and British-Swedish multinational pharmaceutical and biotechnology company AstraZeneca's (LSE: AZN) (STO: AZN) (NASDAQ: AZN) trastuzumab deruxtecan has been recommended for approval in the European Union as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti-HER2-based regimens, the companies said.

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

The Committee for Medicinal Products for Human Use of the European Medicines Agency based its positive opinion on results from the DESTINY-Breast03 phase 3 trial, which were published in The New England Journal of Medicine. 

In the DESTINY-Breast03 trial, trastuzumab deruxtecan 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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