8 May 2018 - The treatment demonstrates a 65% reduction in disease progression or death.

AstraZeneca today announced Health Canada's approval for Lynparza (olaparib) tablets, as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed (PSR), high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy. Marketing authorisation with conditions has been granted for treatment of patients with BRCA wild type status, pending the results of trials to verify its clinical benefit. The indication also coincides with the approval of a new tablet formulation of Lynparza, which reduces daily pill intake from 16 capsules to four tablets daily.

Two randomised trials supported the new approval:

• SOLO-2 (n=295) confirmed the benefit of Lynparza in germline BRCA-mutated patients, demonstrating a 70 per cent reduced risk of disease progression or death (HR 0.30 [95% CI, 0.22-0.41], P<0.0001) and improved median progression-free survival (PFS) to 19.1 vs 5.5 months for placebo by investigator-assessed analysis.iv
  
• Study 19 (n=265) showed that Lynparza in patients regardless of BRCA status reduced the risk of disease progression or death by 65 per cent and improved median PFS to 8.4 vs 4.8 compared with placebo by investigator-assessed analysis (HR 0.35 [95% CI, 0.25-0.49], P<0.00001).v The study also showed that Lynparza reduced the risk of disease progression or death by 46 per cent and improved median PFS to 7.4 vs 5.5 compared with placebo in BRCA wild type patients (HR 0.54 [95% CI, 0.34-0.85], P=0.00745).
  

Read AstraZeneca press release