AstraZeneca, Daiichi Sankyo Say FDA Has Accepted Enhertu for Priority Review

By Anthony O. Goriainoff

AstraZeneca PLC and Daiichi Sankyo Co. said Tuesday that Enhertu, a cancer treatment, has been accepted by the U.S. Food and Drug Administration for priority review for patients with previously treated HER2-mutant metastatic non-small cell lung cancer.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease and the designation shortens the review period.

The pharmaceutical companies said the FDA based its decision on a pivotal Destiny-Lung01 trial which showed that Enhertu was the first HER2-directed therapy to show a strong and robust tumor response. It added that the FDA action date for their regulatory decision is during the third quarter of 2022.

The HER2 protein is expressed on the surface of many types of tumors and is one of many biomarkers expressed in breast cancer tumors.

"Enhertu is being further assessed in a comprehensive clinical development program evaluating efficacy and safety across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers," AstraZeneca said.

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

(END) Dow Jones Newswires

April 19, 2022 02:40 ET (06:40 GMT)

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