FDA Grants Priority Review for ENHERTU After 53% Risk Drop in Phase 3 Trial
Daiichi Sankyo and AstraZeneca’s sBLA for ENHERTU has received FDA Priority Review for post-neoadjuvant HER2 positive early breast cancer, with a PDUFA date of July 7, 2026. DESTINY-Breast05 data showed ENHERTU cut invasive disease recurrence risk by 53% (HR=0.47) and delivered a 92.4% 3-year IDFS rate versus 83.7% for T-DM1.
1. Regulatory Milestone
AstraZeneca and Daiichi Sankyo’s supplemental BLA for ENHERTU was accepted and granted FDA Priority Review for post-neoadjuvant HER2 positive early breast cancer, with a PDUFA date set for July 7, 2026, under Project Orbis evaluation.
2. DESTINY-Breast05 Efficacy Results
In the phase 3 DESTINY-Breast05 trial, ENHERTU reduced invasive disease recurrence or death by 53% (HR=0.47; 95% CI: 0.34-0.66; p<0.0001) versus T-DM1, achieving a 92.4% three-year IDFS rate compared to 83.7%, and cut distant recurrence by 51% and brain metastases risk by 36%.
3. Safety Profile
Grade 3 or higher treatment-emergent adverse events occurred in 50.6% of ENHERTU patients versus 51.9% with T-DM1, with ILD events reported at 9.6% versus 1.6%, mostly low grade; two grade 5 ILD cases were noted in the ENHERTU arm.
4. Next Steps and Global Reviews
Regulatory submissions for ENHERTU based on DESTINY-Breast05 are under review in the EU and Japan, and an additional US sBLA for ENHERTU with THP in the neoadjuvant setting has a PDUFA date of May 18, 2026.