ENHERTU Plus Pertuzumab Granted Priority Review for HER2 Positive Breast Cancer

What's Happening?

Daiichi Sankyo and AstraZeneca's supplemental Biologics License Application for ENHERTU in combination with pertuzumab has been granted Priority Review by the FDA for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer. The application is based on data from the DESTINY-Breast09 phase 3 trial, which showed a 44% reduction in the risk of disease progression or death compared to the current standard of care. The FDA's Priority Review designation indicates that the treatment could offer significant improvements over existing options.

Why It's Important?

The Priority Review for ENHERTU plus pertuzumab is a significant development in the treatment of HER2 positive metastatic breast cancer, potentially offering a new standard of care. The trial results demonstrate a substantial improvement in progression-free survival, which is crucial for patients with aggressive forms of breast cancer. This advancement could lead to better outcomes and extended survival for patients, addressing a critical need in oncology treatment.

What's Next?

The FDA's decision on the application is expected by January 23, 2026. If approved, ENHERTU plus pertuzumab could become a first-line treatment option, providing patients with earlier access to effective therapy. Daiichi Sankyo and AstraZeneca will continue to collaborate on the development and commercialization of ENHERTU, with ongoing trials and research aimed at further understanding its efficacy and safety.

Beyond the Headlines

The development of ENHERTU plus pertuzumab highlights the importance of innovation in cancer treatment, particularly in addressing unmet needs in aggressive forms of breast cancer. The collaboration between Daiichi Sankyo and AstraZeneca reflects broader trends in pharmaceutical partnerships, driving advancements in oncology care. Ethical considerations in drug development and patient access remain critical, ensuring that new treatments are both effective and accessible.