AstraZeneca's Enhertu Granted Priority Review by US Regulator
January 17 2022 - 2:54AM
Dow Jones News
By Anthony O. Goriainoff
AstraZeneca PLC said on Monday that its breast cancer drug,
Enhertu, has been granted priority review by the U.S. Food and Drug
Administration.
The London-listed pharmaceutical company said the supplemental
Biologics License Application, sBLA, was for patients with
HER2-positive metastatic breast cancer treated with a prior
anti-HER2-based regimen.
HER2 is a growth-promoting protein seen on the surface of many
types of tumors, including breast, gastric, lung and colorectal
cancers.
Enhertu is being jointly developed by AstraZeneca and Daiichi
Sankyo Co.
The company said the FDA grants Priority Review to applications
for medicines that, if approved, would offer significant
improvements over available options, and that the sBLA was being
reviewed under the Real-Time Oncology Review program and Project
Orbis. It added that both of these FDA initiatives are designed to
bring effective cancer treatments to patients as early as
possible.
"The Priority Review in the U.S. ... is so important because it
speaks to the transformative potential of Enhertu based on the
unprecedented progression-free survival benefit in this setting.
The news reinforces the importance of bringing this potential new
option to patients as quickly as possible," the company said.
Write to Anthony O. Goriainoff at
anthony.orunagoriainoff@dowjones.com
(END) Dow Jones Newswires
January 17, 2022 02:39 ET (07:39 GMT)
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