Shots:
- The approval is based on a biomarker subgroup analysis of P-III PAOLA-1 study assessing Lynparza + bevacizumab vs bevacizumab alone as 1L maintenance treatment in patients with newly diagnosed advanced FIGO Stage III-IV high-grade serous/ endometrioid ovarian, fallopian tube, peritoneal cancer who had CR/PR to 1L treatment with Pt. based CT and bevacizumab
- Results: reduction in risk of disease progression or death by 67%, PFS (37.2mos. vs 17.7mos.); PFS2 (50.3mos. vs 35.3mos.)
- Following the approval, AZ will receive $25M as a regulatory milestone from MSD. The approval follows the CHMP’s positive opinion granted in Sept’2020
Click here to read the full press release/ article | Ref: AstraZeneca | Image: Pharmaceutical Technology
The post AstraZeneca and MSD’s Lynparza (olaparib) Receive EU’s Approval as 1L Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer first appeared on PharmaShots.