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US FDA accepts regulatory submission for Lynparza
US FDA accepts regulatory submission for Lynparza.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 9743G AstraZeneca PLC 12 November 2018 \n\n12 November 2018 07:05 GMT \n \nUS FDA accepts regulatory submission for Lynparza maintenance therapy in newly-diagnosed, BRCA-mutated advanced ovarian cancer \nand grants Priority Review\n \nApproval would expand use of AstraZeneca and MSD's Lynparza to\npatients in the 1st-line setting following platinum-based chemotherapy\n \nFirst US regulatory submission acceptance for a PARP inhibitor\nas a 1st-line maintenance treatment for advanced ovarian cancer\n \nAstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Priority Review for the use of Lynparza (olaparib) tablets as a maintenance treatment in patients with newly-diagnosed, BRCA-mutated (BRCAm) advanced ovarian cancer who were in complete or partial response following 1st-line standard platinum-based chemotherapy. A Prescription Drug User Fee Act (PDUFA) date is set for the first quarter of 2019.\n \nThis is the first US regulatory submission acceptance for a poly ADP-ribose polymerase (PARP) inhibitor in the 1st-line maintenance setting for advanced ovarian cancer, and if approved will be the fourth indication for Lynparza in the US.\n \nThis submission was based on positive results from the pivotal Phase III SOLO-1 trial. The trial showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for Lynparza compared to placebo, reducing the risk of disease progression or death by 70% in patients with newly-diagnosed, BRCAm advanced ovarian cancer who were in complete or partial response to platinum-based chemotherapy (HR 0.30 [95% CI 0.23-0.41], p<0.001). Of those receiving Lynparza, 60% remained progression-free at 36 months compared to 27% of women in the placebo arm. These data were recently presented for the first time at the ESMO 2018 Congress (European Society for Medical Oncology) and published online in the New England Journal of Medicine.\n \nLynparza is currently approved in over 60 countries for the treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA status. It is also approved in several countries, including the US an...