WILMINGTON, Del. — The U.S. Food and Drug Administration has granted Priority Review to a supplemental Biologics License Application for ENHERTU (fam-trastuzumab deruxtecan-nxki) as a post-neoadjuvant treatment for adults with HER2-positive early breast cancer who have residual invasive disease following HER2-targeted therapy before surgery, AstraZeneca and Daiichi Sankyo announced.
The application seeks approval for use of the therapy in patients whose cancer remains after receiving neoadjuvant treatment, a group considered at higher risk for recurrence. The FDA’s action date under the Prescription Drug User Fee Act is expected in the third quarter of 2026.
Priority Review status is granted to drugs that may offer significant improvements in safety or effectiveness compared with existing therapies or that address serious conditions with unmet medical needs. ENHERTU previously received Breakthrough Therapy Designation from the FDA for this treatment setting.
The regulatory filing is based on results from the Phase III DESTINY-Breast05 trial, which showed the drug significantly reduced the risk of invasive disease recurrence or death compared with trastuzumab emtansine (T-DM1), the current standard treatment for many patients in this setting.
In the study, ENHERTU reduced the risk of invasive disease recurrence or death by 53 percent compared with T-DM1. Patients treated with ENHERTU achieved a three-year invasive disease-free survival rate of 92.4 percent, compared with 83.7 percent among patients receiving T-DM1.
Susan Galbraith, Executive Vice President of Oncology Haematology R&D at 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.”
The study also found that ENHERTU reduced the risk of overall disease recurrence or death by 53 percent and lowered the risk of distant recurrence by 51 percent compared with T-DM1. In addition, the therapy reduced the risk of brain metastases by 36 percent.
Ken Takeshita, Global Head of R&D at Daiichi Sankyo, said: “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.”
About one in five breast cancers are HER2-positive, a subtype often associated with more aggressive disease. Roughly half of patients with HER2-positive early breast cancer still have residual disease after neoadjuvant therapy, increasing their risk of recurrence even after surgery and additional treatment.
Regulatory submissions based on the DESTINY-Breast05 trial are also under review in the European Union and Japan. ENHERTU is already approved in more than 90 countries for the treatment of patients with HER2-positive metastatic breast cancer.
The therapy is an antibody-drug conjugate engineered to target HER2-expressing cancer cells and deliver a cytotoxic payload directly to tumors. It was discovered by Daiichi Sankyo and is being jointly developed and commercialized with AstraZeneca.
