Daiichi Sankyo And AstraZeneca's Supplemental Biologics License Application For ENHERTU® Accepted And Granted Priority Review By The FDA For Patients With Metastatic HER2 Positive Solid Tumors
Author: Benzinga Newsdesk | January 29, 2024 03:19am
Application based on results from DESTINY-PanTumor02 trial and supported by additional ENHERTU data
Submission to be reviewed under FDA Real Time Oncology Review and Project Orbis
If approved, Daiichi Sankyo and AstraZeneca's ENHERTU will potentially be the first HER2 directed treatment and antibody drug conjugate to receive a tumor agnostic indication