FDA Approval Insights: T-DXd for Early-Stage HER2+ Breast Cancer: With Charles E. Geyer, MD

In today’s episode, we welcomed Charles E. Geyer, MD, to discuss recent FDA approvals of fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for the management of HER2-positive breast cancer. Dr Geyer is a professor of medicine and chief of Malignant Hematology and Medical Oncology in the Department of Medicine at the University of Pittsburgh and the University of Pittsburgh Medical Center Hillman Cancer Center in Pennsylvania.

On May 15, 2026, the FDA approved T-DXd for the neoadjuvant treatment of adult patients with HER2-positive stage II or III breast cancer, as determined by an FDA-authorized test, followed by a taxane, trastuzumab (Herceptin), and pertuzumab (Perjeta); the regulatory agency simultaneously approved post-neoadjuvant T-DXd for the treatment of adult patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment.

In our exclusive interview, Dr Geyer discussed the significance of these approvals, key data from the pivotal trials, and how these new indications for T-DXd are shaking up the HER2-positive breast cancer treatment paradigm.