Animedix

Datroway (datopotamab deruxtecan) PDUFA Date (Daiichi Sankyo / AstraZeneca)

FDA PDUFA decision date for Datroway (datopotamab deruxtecan) is June 2, 2026. Developed by Daiichi Sankyo / AstraZeneca. Indication: First-line metastatic triple-negative breast cancer (TNBC). Current status: Approved.

Indication

First-line metastatic triple-negative breast cancer (TNBC)

Notes

Updated PDUFA date (was June 15). Already approved for NSCLC.

Regulatory details

  • Company: Daiichi Sankyo / AstraZeneca
  • Therapeutic area: Oncology
  • Application type: sBLA
  • Review type: Priority
  • PDUFA date: 2026-06-02
  • Outcome: Approved
Datroway (datopotamab deruxtecan) PDUFA Date — Daiichi Sankyo / AstraZeneca