Catalyst overview
Research summary
This catalyst tracks a Approved quarterly sales for Enhertu in 1L HER2-positive Metastatic Breast Cancer. The expected timing is based on the latest available company guidance and may change.
DESTINY-Breast09 Trial. 9/24/25- Granted priority review. PDUFA during Q1 2026. 12/15/25:- US approval for 1L HER2-positive metastatic breast cancer; DESTINY-Breast09 showed >3-year median PFS vs THP. 05/22/26:- DESTINY-Breast09 response analysis presented May 31, 2026. 07/23/26:- CHMP recommended EU approval for Enhertu plus pertuzumab in 1L HER2+ metastatic breast cancer.
Verification
Confirm timing and program details against the company announcement or filing.