US and EU regulatory progress for Enhertu in breast cancer
Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE: AZN) have announced regulatory advancements for Enhertu (trastuzumab deruxtecan), in the treatment of certain people with brease cancer.
The US Food and Drug Administration has granted Enhertu its eighth Breakthrough Therapy designation, this time for the treatment of unresectable or metastatic hormone receptor positive HER2 low or HER2 ultralow breast cancer.
The designation covers use of the therapy in patients who have received specific lines of endocrine therapy, and follows promising results from the Phase III DESTINY-Breast06 trial.
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