By Joe Hoppe

 

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

The pharmaceutical major said its supplemental biologics license application, or sBLA, for Enhertu has been accepted and granted priority review following positive results from a Phase 3 trial.

The U.S. Food and Drug Administration grants priority review status to medicinal applications, which if approved, would offer significant improvements over available options.

Data from the trial showed the drug is the first treatment directed at the HER2 protein to demonstrate a survival benefit in patients with HER2-low metastatic breast cancer. The company said in June that Enhertu reduced the risk of breast cancer progression or death by around 50% compared with chemotherapy.

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors, including breast cancer, and is a biomarker expressed in breast cancer tumors.

"If approved, Enhertu will redefine how we classify and treat metastatic breast cancer, enabling patients whose tumors have lower levels of HER2 expression the opportunity to benefit from a HER2-directed therapy," said Susan Galbraith, AstraZeneca's executive vice president of Oncology R&D.

Enhertu is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo Co., the company said.

 

Write to Joe Hoppe at joseph.hoppe@wsj.com

 

(END) Dow Jones Newswires

July 25, 2022 02:36 ET (06:36 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.
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