AstraZeneca and Daiichi Sankyo have taken a major step towards expanding the use of their cancer therapy, Enhertu (trastuzumab deruxtecan).
The companies have announced that the FDA has accepted their supplemental Biologics License Application (sBLA) and granted Priority Review for adult patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted therapy.
Priority Review is reserved for treatments that could offer significant improvements over existing options, either by enhancing safety or efficacy, preventing serious conditions, or improving patient compliance. The FDA’s Prescription Drug User Fee Act date—its target for regulatory action—is expected in the third quarter of 2026.
Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population. The sBLA is also part of Project Orbis, allowing concurrent review across participating international regulators.
HER2-positive breast cancer accounts for roughly one in five cases and is often linked to aggressive disease and poor outcomes. Up to half of early-stage patients still have residual disease after pre-surgery treatment, putting them at high risk for recurrence. Even with current post-neoadjuvant therapies, many progress to metastatic disease, where five-year survival plummets from nearly 90% to about 30%.
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “While there has been significant progress in treating HER2-positive early breast cancer, managing patients at a higher risk of recurrence remains challenging. With this Priority Review, we move closer to bringing Enhertu to the post-neoadjuvant setting, offering more patients the opportunity for sustained long-term outcomes and a potential path to cure.”
Ken Takeshita, Global Head, R&D, Daiichi Sankyo, added: “For patients with residual invasive disease after neoadjuvant therapy, identifying additional treatments following surgery is critical to help further reduce the risk of recurrence and help prevent progression to metastatic disease. This Priority Review reinforces the potential of Enhertu to become a new standard of care for HER2-positive early breast cancer based on the results of DESTINY-Breast05.”
The sBLA is supported by data from the DESTINY-Breast05 Phase III trial, presented at the 2025 ESMO Congress and published in The New England Journal of Medicine. The study showed Enhertu slashed the risk of invasive disease recurrence or death by 53% compared with trastuzumab emtansine (T-DM1), with a three-year invasive disease-free survival rate of 92.4% versus 83.7% for T-DM1. Benefits were consistent across all subgroups.
