17th Dec 2019 18:36
(Alliance News) - AstraZeneca PLC said Tuesday that US Food & Drug Administration recommended its drug Lynparza for the 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer.
AstraZeneca co-develops and co-commercialises Lynparza, together with Merck & Co Inc, known as MSD outside the United States and Canada.
The drugmaker said in August, the FDA accepted the supplemental New Drug Application for Lynparza for this indication with Priority Review and set a Prescription Drug User Fee Act date for the fourth quarter of 2019.
The supplemental New Drug Application submission was based on the positive results from the Phase III POLO trial.
Lynparza nearly doubled the time patients with germline BRCA-mutated metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months compared to 3.8 months on placebo, the company said.
AstraZeneca shares closed 0.8% higher in London at 7,450.00 pence each on Tuesday.
By Loreta Juodagalvyte; [email protected]
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