Enhertu followed by THP supplemental biologics license application accepted in the U.S. for patients with high-risk HER2 positive early-stage breast cancer prior to surgery

CAR-T Digest - August 2020

Weekly Digest - October 2025

01 October 2025: Enhertu followed by THP supplemental biologics license application accepted in the U.S. for patients with high-risk HER2 positive early-stage breast cancer prior to surgery

The U.S. FDA has accepted a supplemental BLA for Daiichi Sankyo and AstraZeneca’s Enhertu followed by paclitaxel, trastuzumab, and pertuzumab (THP) for the neoadjuvant treatment of high-risk, HER2-positive stage 2 or 3 early-stage breast cancer
The application is supported by the Phase 3 DESTINY-Breast11 trial, the first study to show benefit of Enhertu in early-stage breast cancer
Trial results showed Enhertu followed by THP significantly improved pathologic complete response (pCR) rates and had a better safety profile compared to the current ddAC-THP regimen, with early positive trends in event-free survival (EFS)
The FDA target action date (PDUFA date) is May 18, 2026.
With about one-third of early-stage breast cancer patients considered high-risk and nearly half not achieving pCR with current neoadjuvant regimens, ENHERTU could provide a new treatment approach to improve long-term outcomes