FDA Grants Priority Review to ENHERTU for HER2-Positive Metastatic Breast Cancer Treatment

What's Happening?

AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application for ENHERTU, in combination with pertuzumab, has been accepted and granted Priority Review by the FDA for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. This decision follows the results of the DESTINY-Breast09 Phase III trial, which demonstrated that ENHERTU plus pertuzumab reduced the risk of disease progression or death by 44% compared to the current standard of care. The FDA's Priority Review designation is given to applications that offer significant improvements over existing treatments. The Prescription Drug User Fee Act date for the FDA's regulatory decision is anticipated in the first quarter of 2026.

Why It's Important?

The FDA's Priority Review for ENHERTU represents a potential shift in the standard of care for HER2-positive metastatic breast cancer, a condition affecting 15% to 20% of patients with metastatic breast cancer. The trial results indicate a significant improvement in progression-free survival, which could lead to better patient outcomes. If approved, this treatment could become a new first-line option, offering hope to approximately 10,000 patients treated annually in the U.S. in this setting. The accelerated review process underscores the urgency and potential impact of this treatment in addressing unmet medical needs.

What's Next?

The FDA's decision on ENHERTU's application is expected in early 2026. If approved, AstraZeneca and Daiichi Sankyo will move forward with making ENHERTU available as a first-line treatment option. The Real-Time Oncology Review program, under which the application is being reviewed, aims to expedite the availability of effective cancer treatments. Stakeholders, including healthcare providers and patients, are likely to closely monitor the FDA's decision, as it could influence treatment protocols and patient care strategies.

Beyond the Headlines

The acceptance of ENHERTU for Priority Review highlights the evolving landscape of cancer treatment, where precision medicine and targeted therapies are increasingly prioritized. The trial's success may encourage further research into combination therapies for other aggressive cancers, potentially leading to breakthroughs in treatment approaches. Ethical considerations regarding access to such advanced treatments and their cost implications may also arise as the healthcare industry adapts to new standards.