Weekly Digest - April 2024

2 Apr 2024: Datopotamab deruxtecan BLA accepted in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer

  • AstraZeneca and Daiichi Sankyo’s BLA for Datopotamab deruxtecan in HR-positive, HER2-negative breast cancer accepted in the US
  • Datopotamab deruxtecan showed significant improvement in progression-free survival (PFS) compared to chemotherapy in Phase III trial
  • If approved, Datopotamab deruxtecan could offer an alternative to chemotherapy for patients with advanced breast cancer
  • Safety profile consistent with other trials; no new safety concerns identified
  • Additional BLA for Datopotamab deruxtecan under review for non-small cell lung cancer; global clinical trials ongoing for multiple cancer types

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