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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 firstname.lastname@example.org
(END) Dow Jones Newswires
December 30, 2019 07:34 ET (12:34 GMT)
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