Catalyst overview
Research summary
This catalyst tracks a Approved update for Enhertu in Early-stage HER2+ breast cancer (neoadjuvant). The expected timing is based on the latest available company guidance and may change.
DESTINY-Breast11 trial. 10/1/25- sBLA accepted with PDUFA date May 18, 2026. 04/29/26:- DESTINY-Breast11 gained China approval for neoadjuvant HER2+ stage II-III breast cancer. 05/13/26:- FDA approved neoadjuvant Enhertu followed by THP for Stage II-III HER2+ breast cancer; DESTINY-Breast11.
Verification
Confirm timing and program details against the company announcement or filing.