AstraZeneca's (AZN) Enhertu Gets FDA Nod for Solid Tumors

AstraZeneca (AZN) and partner Daiichi Sankyo announced that the FDA has granted accelerated approval to their drug Enhertu for treating unresectable or metastatic HER2-positive solid tumors in heavily pretreated patients.The approval was based on data from the three phase II studies, including the DESTINY-PanTumor02 study on Enhertu, which showed clinically meaningful responses across a broad range of tumors. The accelerated approval was based on positive objective response rate (ORR) and duration of respon ...