Monday, May 18, 2026
Approved
approved Note: Approved 2026-05-15 as ENHERTU (SUPPL BLA761139). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-07-30; 3d from the PDUFA date.
Drug Information
- Application Type
- sBLA
- Indication
- HER2-positive early breast cancer (neoadjuvant, DESTINY-Breast11)
- Approved As
- Enhertu (trastuzumab deruxtecan) - neoadjuvant
Filing Details
- Company
- AstraZeneca PLC →
- Stock Ticker
- AZN
- SEC CIK
- 0000901832
- Source
- Company IR →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
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Data sourced from SEC EDGAR filings. Last updated: 2026-04-20. Report an issue