First approval in the EU for Daiichi Sankyo and AstraZeneca’s Datroway
Datroway (datopotamab deruxtecan) has been approved in the European Union (EU) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting.
The drug, which is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC), was discovered by Japan’s Daiichi Sankyo (TYO: 4568) and is being jointly developed and commercialized by Daiichi Sankyo and UK pharma major AstraZeneca (LSE: AZN).
The approval by the European Commission follows the positive opinion of the Committee for Medical Products for Human Use of the European Medicines Agency and is based on results from the TROPIONBreast01 Phase III trial. It also follows recent approvals in Japan and the USA.
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