FDA Accepts sNDA for Lynparza for Maintenance Therapy in Advanced Ovarian Cancer and Grants Priority Review

FDA Accepts sNDA for Lynparza for Maintenance Therapy in Advanced Ovarian Cancer and Grants Priority Review

Source: 
CP Wire
snippet: 
  • PDUFA date set for 1Q 2019
  • This is the first regulatory submission acceptance for a poly ADP-ribose polymerase (PARP) inhibitor in the advanced ovarian cancer 1st-line maintenance setting