FDA Approval of Trastuzumab Deruxtecan: Advancing Treatment for HR-Positive HER2-Low and Ultralow Metastatic Breast Cancer
Highlight
– The FDA approved trastuzumab deruxtecan (T-DXd) for adult patients with unresectable or metastatic HR-positive breast cancer exhibiting HER2-low or HER2-ultralow expression after progression on endocrine therapy.
– This approval was based on DESTINY-Breast06, a pivotal multicenter randomized controlled trial demonstrating significant progression-free survival (PFS) improvement compared with chemotherapy.
– The indication includes a newly defined HER2-ultralow category (IHC 0 with membrane staining), supported by an approved diagnostic assay.
– T-DXd provides a novel treatment alternative in the metastatic setting without prior chemotherapy exposure, expanding options beyond standard endocrine and chemotherapy regimens.
Study Background and Disease Burden
Sign in free to continue reading
Create or use your MedXY account to unlock the complete article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.