Enhertu Gets FDA Priority Review for Early Breast Cancer — PDUFA July 7
By FieldPulse Editorial · March 27, 2026
Tags: FDA, Oncology, Pipeline
AstraZeneca and Daiichi Sankyo's Enhertu received FDA Priority Review for post-neoadjuvant HER2+ early breast cancer. The DESTINY-Breast05 trial showed a 53% reduction in recurrence or death vs T-DM1.
The FDA has granted Priority Review to Enhertu (trastuzumab deruxtecan) for the treatment of HER2-positive early breast cancer in the post-neoadjuvant setting.
The Prescription Drug User Fee Act (PDUFA) target date is set for July 7, 2026 .
The supplemental BLA was filed jointly by AstraZeneca and Daiichi Sankyo , the co-development partners behind what has become one of the most commercially significant oncology assets in the industry.
The filing is based on data from the DESTINY-Breast05 (DB-05) trial, which demonstrated a 53% reduction in the risk of invasive disease recurrence or death compared to trastuzumab emtansine (T-DM1) , marketed by Roche/Genentech as Kadcyla.
T-DM1 has been the standard of care in this setting since 2019, based on the KATHERINE trial.
Enhertu's ability to cut recurrence risk by more than half over T-DM1 represents a significant potential shift in the treatment paradigm.
Why This Indication Expansion Matters Enhertu is already approved and widely used in metastatic HER2-positive and HER2-low breast cancer , where it has established itself as a transformative therapy.
But the move into early breast cancer — specifically, patients who have residual disease after neoadjuvant (pre-surgery) treatment — dramatically expands the addressable patient population.
The post-neoadjuvant HER2+ early breast cancer setting represents a large, well-defined patient group.
These are patients who received standard HER2-targeted therapy before surgery but still had cancer remaining in the surgical specimen — a finding that indicates higher risk of recurrence and historically poorer long-term outcomes.
Until now, T-DM1 has been the go-to post-surgical treatment for these patients.
If Enhertu is approved in this setting, it would directly displace T-DM1 for most eligible patients, based on the DB-05 superiority data.
The commercial implications are substantial.
Enhertu already generates billions in annual revenue.
Adding an early breast cancer indication — whe.