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

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Ref: AstraZeneca | Image: AstraZeneca