AstraZeneca PLC announced that Enhertu has been approved by the US FDA on May 18, 2026, for two new indications in treating HER2-positive early breast cancer before and after surgery, reflecting significant progress in treatment options and improving patient outcomes. The approval triggers a milestone payment of $155 million to Daiichi Sankyo, with Enhertu showing a pathologic complete response rate of 67.3% and a 53% reduction in recurrence risk, compared to current standards.