AstraZeneca's Enhertu Breast Cancer Treatment Approved for Use in US
08 Agosto 2022 - 1:50AM
Noticias Dow Jones
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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