FDA session: HR+ Metastatic Breast Cancer in 2025: Progress, Regulatory Approvals, and the Trials Ahead
Session Details
This FDA-led session will review recent approvals for HR+ metastatic breast cancer in 2025—including imlunestrant, Dato-DXd, and T-DXd—and explore the challenges of designing relevant clinical trials amid a rapidly evolving treatment landscape, addressing issues such as control arm selection, emerging biomarkers, patient-centered endpoints, and the regulatory outlook for novel surrogate measures like ctDNA clearance.
Moderator
Laleh Amiri-Kordestani
Moderator
Angela DeMichele, University of Pennsylvania, Philadelphia, PA
2025 FDA Approvals for HR+ Metastatic Breast Cancer
Melanie Royce
2025 FDA Approvals for HR+ Metastatic Breast Cancer
Maria Garcia-Jimenez
Designing Clinical Trials in HR+ Metastatic Breast Cancer: Navigating a Crowded Therapeutic Landscape
Angela DeMichele, University of Pennsylvania, Philadelphia, PA
Panelist
Christy Osgood
Panelist
Stephanie Walker