Datopotamab deruxtecan biologics license application accepted in the US for patients with previously treated metastatic HR positive, HER2 negative breast cancer

Daiichi Sankyo

2 April 2024 - Application based on results from the TROPION-Breast01 Phase 3 trial.

Daiichi Sankyo and AstraZeneca’s biologics license application for datopotamab deruxtecan has been accepted in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior systemic therapy for unresectable or metastatic disease.

Read Daiichi Sankyo press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Dossier