Dual validation for Dato-DXd filings

4 March 2024

The European Medicines Agency (EMA) has validated two marketing authorization applications (MAAs) for AstraZeneca (LSE: AZN) and Daiichi Sankyo’s (TYO: 4568) datopotamab deruxtecan (Dato-DXd) in two types of cancer.

One MAA is for the treatment adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who require systemic therapy following prior treatment.

The other is for the treatment of adults with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have progressed on and are not suitable for endocrine therapy and received at least one additional systemic therapy.

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