On 18 January 2025, Daiichi Sankyo announced that Daiichi/AstraZeneca’s antibody drug conjugate Datroway® (datopotamab deruxtecan-dlnk) has been approved in the US for treatment of adults with unresectable or metastatic hormone receptor positive HER2 negative breast cancer who have received prior endocrine-based therapy and chemotherapy. According to Daiichi, the drug will be available in the US by prescription in approximately two weeks.
This comes less than a month after Japan became the first country globally to approve Datroway® for the same indication, on 27 December 2024.
Daiichi and AstraZeneca are also pursing regulatory approval of Datroway® for the treatment of non-small cell lung cancer (NSCLC) in the US. On 13 January 2025, the companies announced that the FDA has granted datopotamab deruxtecan Priority Review for patients with previously treated advanced EGFR-mutated NSCLC.
However, as of 24 December 2024, AstraZeneca/Daiichi have voluntarily withdrawn the marketing authorisation application (MAA) in the EU for datopotamab deruxtecan for the NSCLC indication, based on feedback from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. According to the companies, they will “continue to work to bring datopotamab deruxtecan to patients with lunch cancer in the EU”. The European application for datopotamab deruxtecan for breast cancer remains under review.
AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise datopotamab deruxtecan (DS-1062) in July 2020.