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AZN : Lynparza-bevacizumab Granted Priority Review In US For Ovarian Cancer

AstraZeneca and Merck & Co. Inc. said that a supplemental New Drug Application for Lynparza in combination with bevacizumab has been accepted and granted Priority Review in the US for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to 1st-line platinum-based chemotherapy with bevacizumab.

A Prescription Drug User Fee Act date is set for the second quarter of 2020.

The investigator-assessed results showed Lynparza added to bevacizumab reduced the risk of disease progression or death by 41% based on a hazard ratio of 0.59 (p<0.0001) and improved progression-free survival to a median of 22.1 months vs. 16.6 months for patients treated with bevacizumab alone.

In a separate press release, AstraZeneca has decided to close the Phase III STRENGTH trial for Epanova due to its low likelihood of demonstrating a benefit to patients with mixed dyslipidaemia who are at increased risk of cardiovascular disease. Previously, Independent Data Monitoring Committee recommended to discontinue
the trial.

The company said it is reviewing the ongoing value of the $533 million Epanova intangible asset. A write down of up to $100 million relating to inventories is also anticipated to impact the Core earnings in the fourth quarter of 2019.

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