Datopotamab deruxtecan (Dato-DXd) in advanced or metastatic HR+/HER2– Breast Cancer

In November 2024’s CHMP agenda, the marketing authorization application for Dato-DXd based on the Phase 3 TROPION-Breast01 trial was listed for review under section “3.1 Initial Applications; List of Outstanding Issues”

• The stated indication under review was “inoperable or metastatic HR+/HER2- BC with disease progression following chemotherapy in the metastatic setting”
• Having received a List of Outstating Issues (LoOI), the CHMP could issue an opinion as early as Dec 2024 (based on the CHMP’s procedural timetables) with EC approval following Feb 2025
  • However, if a “clock stop” is required to respond to the LoOIs, a CHMP opinion could be pushed back to January or February 2025. 

• AstraZeneca has guided for a regulatory decisions based on TROPION-Breast01 in H1 2025 (geography unspecified)