AstraZeneca's Breast-Cancer Drug Gets Priority Review From FDA
October 18 2017 - 3:06AM
Dow Jones News
By Maryam Cockar
AstraZeneca PLC (AZN.LN) on Wednesday said that the U.S. Food
& Drug Administration has granted a priority review to its new
drug application for tablets that treat breast cancer.
The FTSE 100-listed pharmaceutical company said that the
regulator will review its application by the first quarter of 2018.
Lynparza treats patients with germline breast cancer who have been
previously treated with chemotherapy.
AstraZeneca said that the application is based on positive
results from a phase 3 trial published in the New England Journal
of Medicine. Lynparza was approved by the FDA in December 2014 in a
capsule formulation.
Write to Maryam Cockar at maryam.cockar@dowjones.com
(END) Dow Jones Newswires
October 18, 2017 02:51 ET (06:51 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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