AstraZeneca, Merck Get FDA Priority Review for Lynparza in Advanced Ovarian Cancer
January 13 2020 - 7:43AM
Dow Jones News
By Colin Kellaher
AstraZeneca PLC (AZN, AZN.LN) and Merck & Co. (MRK) Monday
said the U.S. Food and Drug Administration accepted and granted
priority review to a supplemental new-drug application for Lynparza
in combination with bevacizumab in advanced ovarian cancer.
The drugmakers said the filing covers the maintenance treatment
of women with advanced ovarian cancer whose disease showed a
complete or partial response to first-line treatment with
platinum-based chemotherapy and bevacizumab.
The FDA grants priority review to medicines that have the
potential to provide significant improvements in the treatment of a
serious disease, and the designation shortens the review
period.
AstraZeneca and Merck, which in 2017 formed a collaboration to
co-develop and co-commercialize AstraZeneca's Lynparza for multiple
cancer types, said the agency has set a target action date for the
second quarter.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
January 13, 2020 07:28 ET (12:28 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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