AstraZeneca, Merck Get FDA OK for Lynparza in Pancreatic Cancer Indication
December 30 2019 - 7:49AM
Dow Jones News
By Colin Kellaher
AstraZeneca PLC (AZN, AZN.LN) and Merck & Co. (MRK) on
Monday said the U.S. Food and Drug Administration approved Lynparza
as a first-line maintenance treatment in a form of pancreatic
cancer.
The companies said the approval covers Lynparza for the
maintenance treatment of adults with deleterious or suspected
deleterious germline BRCA-mutated metastatic pancreatic
adenocarcinoma whose disease hasn't progressed on at least 16 weeks
of a first-line platinum-based chemotherapy regimen.
Merck and AstraZeneca said the approval is based on a phase 3
study in which Lynparza reduced the risk of disease progression or
death by 47% compared to placebo in that patient population.
The companies said patients will be selected for therapy based
on Myriad Genetics Inc.'s (MYGN) BRACAnalysis CDx genetic test,
which the FDA has approved as a companion diagnostic test with
Lynparza in the new indication.
AstraZeneca and Merck in 2017 formed a collaboration to
co-develop and co-commercialize AstraZeneca's Lynparza for multiple
cancer types.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 30, 2019 07:34 ET (12:34 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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