AstraZeneca, Merck Get FDA Priority Review for Lynparza in Form of Prostate Cancer
21 January 2020 - 11:43PM
Dow Jones News
By Colin Kellaher
AstraZeneca PLC (AZN, AZN.LN) and Merck & Co. (MRK) on
Tuesday said the U.S. Food and Drug Administration accepted and
granted priority review to a supplemental new-drug application for
Lynparza in a form of prostate cancer.
The drugmakers said the filing covers the treatment of patients
with metastatic castration-resistant prostate cancer and
deleterious or suspected deleterious germline or somatic homologous
recombination repair gene mutations, who have progressed following
prior treatment with a new hormonal agent.
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 21, 2020 07:28 ET (12:28 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
Merck (NYSE:MRK)
Historical Stock Chart
From Apr 2024 to May 2024
Merck (NYSE:MRK)
Historical Stock Chart
From May 2023 to May 2024