Milestones
- AstraZeneca partnership signedMar 2019Complete.
- FDA: first drug for HER2-low breast cancer (DESTINY-Breast04)5 Aug 2022Complete.
- FDA: first-line HER2+ metastatic, with pertuzumab (DESTINY-Breast09)Dec 2025Complete.
- FDA: early HER2+ breast cancer before and after surgery15 May 2026Complete.
Most important updates
- FDA approves Enhertu for early HER2-positive breast cancer, both before and after surgery15 May 2026
- Enhertu plus pertuzumab approved in the US as first-line treatment for HER2-positive metastatic breast cancer10 Dec 2025
- FDA approves Enhertu as the first treatment for HER2-low breast cancer5 Aug 2022
