Enhertu plus Pertuzumab granted priority review in the US as 1st-line treatment for patients with HER2-positive metastatic breast cancer

CAR-T Digest - August 2020

Weekly Digest - September 2025

24 September 2025: Enhertu plus Pertuzumab granted priority review in the US as 1st-line treatment for patients with HER2-positive metastatic breast cancer

The FDA has granted priority review to Enhertu (Trastuzumab deruxtecan) plus Pertuzumab for 1st-line treatment of HER2-positive metastatic breast cancer, based on DESTINY-Breast09 Phase 3 trial results
The FDA decision (PDUFA date) is expected in Q1 2026, under the Real-Time Oncology Review (RTOR) programme. Enhertu also holds breakthrough therapy designation in this setting
The trial showed Enhertu plus Pertuzumab reduced the risk of progression or death by 44% compared to THP, with median progression-free survival (PFS) of 40.7 months vs. 26.9 months
The confirmed objective response rate was 85.1% (including 58 complete responses) for Enhertu plus pertuzumab vs. 78.6% (33 complete responses) for THP, with a consistent safety profile
If approved, this would mark the first major evolution in 1st-line HER2-positive metastatic breast cancer in over a decade, potentially establishing a new standard of care