AstraZeneca, Merck Say FDA Panel Recommends Lynparza in Pancreatic Cancer
December 17 2019 - 3:05PM
Dow Jones News
By Michael Dabaie
AstraZeneca PLC (AZN) and Merck & Co. Inc. (MRK) said an
U.S. Food and Drug Administration advisory panel voted to recommend
lynparza for first-line maintenance therapy in pancreatic
cancer.
The Oncologic Drugs Advisory Committee voted 7-5 to recommend
lynparza as a first-line maintenance monotherapy for germline
BRCA-mutated metastatic pancreatic cancer, the companies said.
The FDA in August accepted the supplemental New Drug Application
for lynparza for this indication.
The ODAC provides the FDA with independent advice and
recommendations on marketed and investigational medicines for use
in the treatment of cancer. The FDA isn't bound by the committee's
guidance but takes its advice into consideration.
In 2017, AstraZeneca and Merck unveiled an oncology
collaboration to co-develop and co-commercialize lynparza.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
December 17, 2019 14:50 ET (19:50 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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