WILMINGTON, DE — AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) said their jointly developed breast cancer therapy ENHERTU has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, marking the tenth such designation for the drug and strengthening its regulatory momentum in early-stage disease.
The FDA granted the designation for ENHERTU in adult patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant treatment and face a high risk of recurrence. Breakthrough Therapy Designation is intended to accelerate development and regulatory review of treatments that address serious conditions and demonstrate substantial improvement over existing therapies.
The decision was based on results from the Phase III DESTINY-Breast05 trial, which were presented during a Presidential Symposium at the 2025 European Society for Medical Oncology Congress and later published in The New England Journal of Medicine. The trial showed ENHERTU outperforming the current standard of care in reducing the risk of invasive disease recurrence in the post-neoadjuvant setting.
Susan Galbraith, executive vice president of oncology hematology research and development at AstraZeneca, said patients with residual disease after neoadjuvant therapy represent a critical population with limited options. She said the designation reflects the clinical benefit demonstrated by ENHERTU and its potential role in preventing progression to metastatic disease.
Ken Takeshita, global head of research and development at Daiichi Sankyo, said the designation reinforces ENHERTU’s growing impact across multiple stages of breast cancer treatment. He said the companies look forward to working with the FDA to advance the therapy into the post-neoadjuvant setting, citing DESTINY-Breast05 results that suggest improved outcomes compared with existing treatments.
DESTINY-Breast05 is the second positive ENHERTU trial in early breast cancer reported this year. A separate Phase III study, DESTINY-Breast11, which evaluates the drug in high-risk HER2-positive patients in the neoadjuvant setting, remains under FDA review.
ENHERTU is a HER2-directed antibody-drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialized with AstraZeneca. The therapy is already approved across multiple HER2-driven cancers, including metastatic breast cancer, non-small cell lung cancer, gastric cancer, and certain solid tumors, with some indications granted under the FDA’s accelerated approval pathway.
The companies noted that ENHERTU carries important safety warnings, including the risk of interstitial lung disease and embryo-fetal toxicity, which require close monitoring and patient counseling.
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