HER2-Positive Early Breast Cancer With Residual Disease After Neoadjuvant Therapy
AZNAstrazenecaCatalyst overview
Research summary
This catalyst tracks a Approved update for Enhertu/Trastuzumab Deruxtecan (DS-8201a) (HER2-Targeted ADC) in HER2-Positive Early Breast Cancer With Residual Disease After Neoadjuvant Therapy. The expected timing is based on the latest available company guidance and may change.
12/19/25:- BTD granted in US for HER2+ early breast cancer residual disease per DESTINY-Breast05 ESMO25 results. 03/06/26:- U.S. sBLA accepted; Priority Review granted. PDUFA July 7, 2026. 04/29/26:- DESTINY-Breast05 filings accepted in EU, Japan, and China for residual disease. 05/15/26:- FDA approved adjuvant ENHERTU for residual invasive HER2+ breast cancer after neoadjuvant therapy. 05/22/26:- DESTINY-Breast05 ILD and radiation pneumonitis risk analysis presented at ASCO 2026 on Jun 1, 2026. 07/23/26:- EU review ongoing for residual invasive disease after neoadjuvant HER2-targeted treatment.
Verification
Confirm timing and program details against the company announcement or filing.