Enhertu Receives US Approval as First HER2-focused Treatment for Metastatic Solid Tumors, Independent of Tumor Origin
AstraZeneca and Daiichi Sankyo's drug Enhertu (trastuzumab deruxtecan) has gained approval in the United States for treating adult patients with inoperable or metastatic HER2-positive (IHC 3+) solid tumors. This approval is granted under an accelerated process, relying on measures of objective response rate (ORR) and duration of response (DoR). Future approval for this use will depend on confirming and describing its clinical benefits in a follow-up trial.
Enhertu, a HER2-directed antibody-drug conjugate (ADC), was developed by Daiichi Sankyo and...
