T-DXd Granted Breakthrough Therapy Designation by FDA in HER2+ Breast Cancer

T-DXd Breakthrough Designation Signals New Era for HER2-Positive Metastatic Breast Cancer

FDA designates T-DXd plus pertuzumab as breakthrough therapy for HER2-positive metastatic breast cancer, promising improved survival rates for patients.

T-DXd Granted Breakthrough Therapy Designation by FDA in HER2+ Breast Cancer

The regulatory decision is based on data from the phase 3 DESTINY-Breast09 results presented at the 2025 ASCO Annual Meeting.

Daiichi Sankyo and AstraZeneca’s Enhertu breakthrough therapy status

This designation is for its use in combination with pertuzumab as a first-line treatment for adult patients with unresectable or metastatic HER2-positive breast cancer. The FDA’s decision was The post Daiichi Sankyo and AstraZeneca’s Enhertu gains breakthrough therapy status appeared first on Pharmaceutical Business review.