Enhertu (trastuzumab deruxtecan) - post-neoadjuvant

FDA PDUFA Target Action Date · AstraZeneca PLC

Tuesday, July 7, 2026

1 days ago

approved

Drug Information

Drug Name: Enhertu (trastuzumab deruxtecan) - post-neoadjuvant (CT.gov)
Approved As: BAXFENDY →

Filing Details

Company: AstraZeneca PLC →
SEC CIK: 0000901832
Source: SEC 8-K Filing →

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: manual. Report an issue