AstraZeneca, Merck Say FDA Panel Recommends Lynparza in Pancreatic Cancer

Date : 12/17/2019 @ 8:05PM
Source : Dow Jones News
Stock : AstraZeneca PLC (AZN)
Quote : 49.31  0.2 (0.41%) @ 10:33PM
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AstraZeneca, Merck Say FDA Panel Recommends Lynparza in Pancreatic Cancer

AstraZeneca (NYSE:AZN)
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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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