AstraZeneca's Enhertu Granted Priority Review by US Regulator

By Anthony O. Goriainoff

AstraZeneca PLC said on Monday that its breast cancer drug, Enhertu, has been granted priority review by the U.S. Food and Drug Administration.

The London-listed pharmaceutical company said the supplemental Biologics License Application, sBLA, was for patients with HER2-positive metastatic breast cancer treated with a prior anti-HER2-based regimen.

HER2 is a growth-promoting protein seen on the surface of many types of tumors, including breast, gastric, lung and colorectal cancers.

Enhertu is being jointly developed by AstraZeneca and Daiichi Sankyo Co.

The company said the FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options, and that the sBLA was being reviewed under the Real-Time Oncology Review program and Project Orbis. It added that both of these FDA initiatives are designed to bring effective cancer treatments to patients as early as possible.

"The Priority Review in the U.S. ... 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," the company said.

Write to Anthony O. Goriainoff at [e-mail]

(END) Dow Jones Newswires

January 17, 2022 02:39 ET (07:39 GMT)

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