AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan receives US FDA acceptance for BLA to treat HR-positive, HER2-negative breast cancer patients.
AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan (Dato-DXd) received US FDA acceptance for a Biologics License Application (BLA) to treat adult patients with HR-positive, HER2-negative breast cancer who've received prior systemic therapy. The BLA is based on the TROPION-Breast01 Phase III trial, which showed PFS improvement. The FDA action date is Q1 2025.
April 02, 2024
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