US Food and Drug Administration Approval Summary: Fam-Trastuzumab Deruxtecan-nxki for Human Epidermal Growth Factor Receptor 2-Low Unresectable or Metastatic Breast Cancer.

Preeti Narayan Asma DilawariChristy OsgoodZhou Feng Erik W Bloomquist William F Pierce Samina JafriShyam KalavarMarina KondratovichPrakash JhaSoma GhoshShenghui Tang Richard PazdurJulia A BeaverLaleh Amiri-Kordestani

Published in: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2023)

The approval of T-DXd in HER2-low metastatic breast cancer was based on statistically significant and clinically meaningful PFS and OS improvements observed in the DESTINY-Breast04 trial and represents the first approved therapy specifically for the treatment of HER2-low metastatic breast cancer.

Keyphrases

metastatic breast cancer
drug administration
epidermal growth factor receptor
tyrosine kinase
endothelial cells
advanced non small cell lung cancer
clinical trial
randomized controlled trial
phase iii
climate change
radiation therapy
phase ii
human health
liver metastases