By Joe Hoppe

 

AstraZeneca PLC said Monday that its Enhertu metastatic breast cancer treatment has been approved for use in the U.S. by the Food and Drug Administration.

The pharmaceutical major said its treatment has been approved following positive results from a Phase 3 trial, and it can now be used for treating adult patients with unresectable or metastatic HER2-low breast cancer who have received chemotherapy previously in a metastatic setting, or developed a recurrence of the disease within six months of completing chemotherapy.

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, AstraZeneca said. 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.

The treatment had secured priority review from the FDA on July 25.

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

August 08, 2022 02:35 ET (06:35 GMT)

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