17 January 2022 - Application being evaluated under FDA Real-Time Oncology Review and Project Orbis
Daiichi Sankyo and AstraZeneca have received notification of acceptance by the U.S. FDA of the supplemental biologics license application of Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients in the U.S. with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2-based regimen.