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AstraZeneca, Daiichi breast cancer drug set for speedy FDA review

July 25, 2022

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The Food and Drug Administration has agreed to quickly review AstraZeneca and Daiichi Sankyo’s drug Enhertu for treating metastatic breast cancer that expresses low levels of a protein known as HER2. If approved, the therapy would become the first targeted option for this type of tumor, potentially reshaping how doctors categorize and treat advanced breast cancer.

The FDA’s review, announced by the companies Monday, comes nearly two months after researchers presented clinical trial results that showed Enhertu halved the risk of breast cancer progression versus chemotherapy for patients with this kind of tumor, and cut the risk of death by more than a third.

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