EMA validates MAAs for AstraZeneca & Daiichi Sankyo's datopotamab deruxtecan in NSCLC & HR+/HER2- breast cancer.

The European Medicines Agency (EMA) has validated two marketing authorisation applications (MAAs) for AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan (Dato-DXd) in two types of cancer: non-small cell lung cancer (NSCLC) and hormone receptor (HR)-positive, HER2-negative breast cancer. The validations confirm the completion of the applications and commence the scientific review process by the EMA's Committee for Medicinal Products for Human Use.

March 04, 2024
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