Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours
If approved, AstraZeneca and Daiichi Sankyo’s Enhertu will potentially be the first HER2-directed treatment and antibody drug conjugate to receive a tumour-agnostic indication. 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. AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or