Note: Approved 2026-05-22 (39 days early) as DATROWAY sBLA (SUPPL-3, EFFICACY, BLA761394 in drugs.json) for unresectable or metastatic TNBC in adults who are not candidates for PD-1/PD-L1 inhibitor therapy, based on TROPION-Breast02. Source: Daiichi Sankyo press release, Tokyo, May 22, 2026 https://www.daiichisankyo.com/files/news/pressrelease/pdf/202605/20260522_E2.pdf ; AstraZeneca https://www.astrazeneca.com/media-centre/press-releases/2026/datroway-approved-in-us-for-1l-triple-negative-bc.html
Drug Information
- Application Type
- sBLA
- FDA Designations
- Priority Review
- Indication
- First-line metastatic triple-negative breast cancer (TNBC)
- Approved As
- Datroway (datopotamab deruxtecan)
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