AstraZeneca and Merck’s Lynparza (olaparib) Receive CHMP’s Positive Opinion for 1L Maintenance Treatment of BRCA-Mutated Advanced Ovarian Cancer

AstraZeneca and Merck’s Lynparza (olaparib) Receive CHMP’s Positive Opinion for 1L Maintenance Treatment of BRCA-Mutated Advanced Ovarian Cancer

Shots:

  • The positive opinion is based on SOLO-1 P-III study results assessing Lynparza (300mg, bid) as a monothx vs PBO in 391 patients in ratio (2:1) with BRCAm advanced ovarian cancer following 1L Pt-based CT
  • The study resulted in 70% reduction in the risk of disease progression or death and demonstrated PFS as (60.4% vs 26.9%) in 36 months with no. of patients with event (102 vs 96)
  • Lynparza(olaparib) is a PARP inhibitor targeted to block DNA damage response in cells/tumors harboring a deficiency in homologous recombination repair (HRR). In Jul,2017 AZ and Merck globally collaborated to co-develop and co-commercialize Lynparza  

Click here to read full press release/ article | Ref: AstraZeneca | Image: Barron’s