Shots:
- FDA has accepted an sBLA of neoadj. Enhertu followed by paclitaxel, Herceptin & Perjeta (THP) for the treatment of adults with HER2+ (IHC 3+ or ISH+) stage 2/3 breast cancer (PDUFA: May 18, 2026)
- sBLA was backed by the P-III (DESTINY-Breast11) trial assessing neoadj. Enhertu alone (5.4mg/kg) ± THP vs ddAC + THP in high-risk, locally advanced HER2+ early-stage breast cancer pts (n=927)
- Trial showed improved pCR rate (1EP), with EFS (2EP) depicting an early favorable trend; data to be presented along with P-III (DESTINY-Breast05) trial results at ESMO’25. Also, enrollment in the 3rd arm assessing Enhertu alone is closed following an IDMC recommendation, based on previous efficacy findings
Ref: Daiichi Sankyo | Image: AstraZeneca & Daiichi Sankyo | Press Release
Related News:- Daiichi Sankyo and AstraZeneca Report the Topline P-III (DESTINY-Breast05) Trial Data of Enhertu for High-Risk Early Breast Cancer
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