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July 18, 2025

Daiichi Sankyo and AstraZeneca’s Enhertu gains breakthrough therapy status

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to Enhertu, a targeted HER2-directed antibody-drug conjugate (ADC), discovered by Daiichi Sankyo and collaboratively developed and marketed along with AstraZeneca.

The FDA's decision was based on the results from the DESTINY-Breast09 Phase III trial. Credit: Testalize.me on Unsplash.