SILVER SPRING
Enhertu cleared for HER2-positive breast cancer
- Sponsor
- Daiichi Sankyo $DSKYF
- Drug
- Enhertu · fam-trastuzumab deruxtecan-nxki
- Indication
- HER2-positive breast cancer
FDA approved Enhertu for two new indications in HER2-positive breast cancer patients in neoadjuvant and adjuvant settings.
What this means
Enhertu is a breast cancer treatment that combines a HER2-targeting antibody with a cell-killing drug, delivering the payload directly to tumors. FDA expanded its approval to include use before and after surgery for HER2-positive breast cancer patients. This decision gives doctors a new way to attack aggressive tumors earlier in treatment, potentially improving long-term outcomes for more patients.
Drug Watch — recent news on Enhertu
- EU panel endorses label upgrades for Trodelvy, Enhertu in 1L breast cancer - FirstWord PHARMA
- Enhertu® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer - Business Wire
- CHMP Recommends T-DXd Plus Pertuzumab for First-Line HER2-Positive Metastatic Breast Cancer - OncLive
- AZN Receives Positive EU Recommendation for Enhertu in Breast Ca - GuruFocus
- CHMP Backs Enhertu, Pertuzumab for HER2+ Breast Cancer - Mirage News