AZN
Enhertu (trastuzumab deruxtecan) - post-neoadjuvant
FDA PDUFA Target Action Date · AstraZeneca PLC
Friday, May 15, 2026
Approved April 24, 2026
approved Note: 53% reduction in recurrence/death vs T-DM1. Partner: Daiichi Sankyo. APPROVED May 15, 2026, ~7 weeks ahead of the July 7 PDUFA target (FDA cleared both early-BC indications the same day).
Drug Information
- Application Type
- sBLA
- FDA Designations
- BreakthroughPriority Review
- Indication
- HER2-positive early breast cancer with residual invasive disease (DESTINY-Breast05)
- Approved As
- SAPHNELO →
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