AstraZeneca: approval of Dato-DXd recommended in the EU

(CercleFinance.com) - The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of datopotamab deruxtecan (Dato-DXd), the new antibody conjugate from AstraZeneca and Daiichi Sankyo, the two companies announced on Friday.


The committee's positive opinion applies to previously treated patients with HR-positive/HER2-negative metastatic breast cancer, their press release states.

The European Commission is expected to announce its final decision in the coming months.

Datopotamab deruxtecan (Dato-DXd) has already been approved for this indication in the USA and Japan.

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