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News

Daiichi Sankyo And AstraZeneca's Supplemental Biologics License Application For ENHERTU® Accepted And Granted Priority Review By The FDA For Patients With Metastatic HER2 Positive Solid Tumors

Author: Benzinga Newsdesk | January 29, 2024 03:19am
  • Application based on results from DESTINY-PanTumor02 trial and supported by additional ENHERTU data
  • Submission to be reviewed under FDA Real Time Oncology Review and Project Orbis
  • If approved, Daiichi Sankyo and AstraZeneca's ENHERTU will potentially be the first HER2 directed treatment and antibody drug conjugate to receive a tumor agnostic indication

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