AstraZeneca and Daiichi Sankyo receive FDA priority review for Enhertu in breast cancer
The US Food and Drug Administration has granted priority review to the Enhertu-pertuzumab combination for first-line treatment of HER2-positive metastatic breast cancer.
The US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab, granting it priority review for the first-line treatment of unresectable or metastatic HER2-positive breast cancer. A regulatory decision is anticipated in the first quarter of 2026.
The application is based on results from the DESTINY-Breast09 Phase III trial, which demonstrated that the combination reduced the risk of disease progression or death by 44% compared to the standard therapy regimen of taxane, trastuzumab, and pertuzumab. Clinical data indicated a median progression-free survival of 40.7 months for the Enhertu group, compared to 26.9 months for the control group.
HER2-positive breast cancer remains an aggressive disease that affects approximately 15% to 20% of metastatic breast cancer patients. The current standard of care has seen little evolution in the first-line setting over the past decade, making the potential shift toward an Enhertu-based regimen a significant development for clinical practice.
Enhertu, an antibody-drug conjugate discovered by Daiichi Sankyo and co-developed by AstraZeneca, is currently under review via the FDA’s Real-Time Oncology Review program, which aims to streamline the evaluation of cancer therapies.