# DATROWAY (datopotamab deruxtecan-dlnk) PDUFA Event: First-line unresectable or metastatic triple-negative breast cancer

Canonical URL: https://biopharmsignal.com/pdufa-calendar/AZN/datroway-first-line-metastatic-triple-negative-breast-cancer

Ticker: AZN

Company: AstraZeneca PLC

Event date: 2026-06-02

Event type: FDA Decision

Stage: PDUFA

Result: Approved

Result date: 2026-05-22

Application type: sBLA

FDA approved DATROWAY for first-line metastatic TNBC. FDA approved DATROWAY for adults with unresectable or metastatic triple-negative breast cancer who are...

## Event Timeline

### May 22, 2026 — FDA approved DATROWAY for first-line metastatic TNBC

FDA approved DATROWAY for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.

[FDA — DATROWAY metastatic TNBC approval](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer)

### February 3, 2026 — FDA accepted the sBLA with Priority Review

FDA accepted the application based on TROPION-Breast02, granted Priority Review and assigned a June 2, 2026 PDUFA date.

[Daiichi Sankyo — DATROWAY sBLA acceptance](https://www.daiichisankyo.com/files/news/pressrelease/pdf/202602/20260203_E.pdf)

### October 2025 — TROPION-Breast02 results were presented and published

The Phase 3 study showed significant improvements in overall and progression-free survival versus chemotherapy; results were presented at ESMO and published in Annals of Oncology.

[AstraZeneca — DATROWAY approval and pivotal evidence](https://news.cision.com/astrazeneca/r/datroway-approved-in-us-for-1l-triple-negative-bc%2Cc4352964)

### May 16, 2022 — Phase 3 TROPION-Breast02 study started

The pivotal study began comparing DATROWAY with investigator's-choice chemotherapy in previously untreated unresectable or metastatic TNBC not eligible for immunotherapy.

[ClinicalTrials.gov — TROPION-Breast02 study record (NCT05374512)](https://clinicaltrials.gov/study/NCT05374512)

## Regulatory Designations

- Priority Review FDA: [Daiichi Sankyo — DATROWAY Priority Review and June 2 PDUFA date](https://www.daiichisankyo.com/files/news/pressrelease/pdf/202602/20260203_E.pdf)

## Related Pages

- AZN PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/AZN.md

- AZN company profile: https://biopharmsignal.com/company/AZN.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

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