AstraZeneca, Merck Get FDA Priority Review for Lynparza in Form of Prostate Cancer

Date : 01/21/2020 @ 12:43PM
Source : Dow Jones News
Stock : AstraZeneca PLC (AZN)
Quote : 50.17  1.23 (2.51%) @ 1:00AM
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AstraZeneca, Merck Get FDA Priority Review for Lynparza in Form of Prostate Cancer

Merck (NYSE:MRK)
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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.

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