AstraZeneca's Enhertu Treatment Granted Priority Review Status by FDA
25 Julho 2022 - 3:51AM
Dow Jones News
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)
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