CHMP positive opinion for Lynparza for treatment of BRCA-mutated advanced ovarian cancer

AstraZeneca and MSD Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending Lynparza (olaparib) as a 1st-line maintenance treatment of BRCA-mutated advanced ovarian cancer. The recommendation is for the use of Lynparza tablets as a maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

The positive opinion is based on data from the pivotal Phase III SOLO-1 trial which showed that Lynparza reduced the risk of disease progression or death by 70% vs. placebo following response to platinum-based chemotherapy (HR 0.30 [95% CI 0.23-0.41], p<0.001). Of those patients receiving Lynparza, 60.4% remained progression-free at 36 months vs. 26.9% of women in the placebo arm.