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AstraZeneca's Enhertu granted priority review by US FDA

By Iain Gilbert

Date: Monday 17 Jan 2022

AstraZeneca's Enhertu granted priority review by US FDA

(Sharecast News) - Drugmaker AstraZeneca said on Monday that its Daiichi Sankyo collaboration Enhertu had been granted priority review by the Federal Drug Administration in the US for patients with HER2-positive metastatic breast cancer treated with a prior anti-HER2-based regimen.
AstraZeneca stated the review came hot on the heels of the "ground-breaking" DESTINY-Breast03 test results that showed the drug reduced the risk of disease progression or death by 72% versus trastuzumab emtansine.

If approved, the FTSE 100-listed firm said Enhertu would offer "significant improvements" over available options, with the FDA's action date for its regulatory decision set for some time in the second quarter.

AstraZeneca's Vice President of oncology R&D, Susan Galbraith, said: "This review across geographies and the priority review in the US as part of Project Orbis is so important because it speaks to the transformative potential of Enhertu based on the unprecedented progression-free survival benefit in this setting. The news reinforces the importance of bringing this potential new option to patients as quickly as possible."

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