AstraZeneca’s Lynparza (olaparib) + Bevacizumab Receive the US FDA’s Priority Review for 1L Treatment of Advanced Ovarian Cancers

AstraZeneca’s Lynparza (olaparib) + Bevacizumab Receive the US FDA’s Priority Review for 1L Treatment of Advanced Ovarian Cancers

Shots:

  • The US FDA has accepted the sNDA and granted the PR for Lynparza in combination with bevacizumab as a maintenance therapy for patients with advanced ovarian cancer who are in complete or partial response to 1L platinum-based CT with bevacizumab
  • The PR is based on P-III PAOLA-1 study result assessing the combination therapy vs bevacizumab as monothx., demonstrating reduction in risk of diseases progression or death by 41% and an improvement in PFS (22.1 vs 16.6mos.), @2yrs. following trial initiation, no diseases progression (46% vs 28%)             
  • Lynparza (olaparib) is a first-in-class PARP inhibitor acts by targeting DNA damage response (DDR) in cells/tumors harboring a deficiency in HRR (BRCA1& 2 mutation) with its expected PDUFA date in Q2’20

Click here to­ read full press release/ article | Ref: AstraZeneca | Image: Twitter