Posted by Michael Wonder on 25 Jul 2022
Enhertu granted priority review in the U.S. for patients with HER2 low metastatic breast cancer
25 July 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 (famtrastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic HER2 low (immunohistochemistry 1+ or immunohistochemistry 2+/in situ hybridisation negative) breast cancer who have received a prior therapy in the metastatic setting.
