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By Sabela Ojea
AstraZeneca PLC (AZN.LN) said Monday that its supplemental new drug application for Lynparza has been accepted and granted priority review in the U.S. by the Food and Drug Administration for patients with metastatic castration-resistant prostate cancer.
The pharmaceutical company said that the Prescription Drug User Fee Act date is set for the second quarter of 2020.
The London-listed company said that Lynparza is also aimed at patients with deleterious or suspected deleterious germline or somatic homologous recombination repair gene mutations, which have progressed following prior treatment with a new hormonal agent.
Results of the PROfound trial showed Lynparza significantly reduced the risk of disease progression or death by 66%, it added.
Prostate cancer is the second-most common cancer in men, with an estimated 1.3 million new cases diagnosed world-wide in 2018 and it is associated with a significant mortality rate, AstraZeneca noted.
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(END) Dow Jones Newswires
January 20, 2020 02:31 ET (07:31 GMT)
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