Lynparza approved in the EU for 1st-line maintenance treatment of BRCA-mutated advanced ovarian cancer

AstraZeneca and MSD Inc., announced that the European Commission (EC) has approved Lynparza (olaparib) as a 1st-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer. The licensed indication is 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 1st-line platinum-based chemotherapy.

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “In SOLO-1, Lynparza demonstrated clinically-meaningful results with a 70% reduction in the risk of disease progression or death in the first-line maintenance treatment of patients with BRCAm advanced ovarian cancer. Merck and AstraZeneca are committed to improving outcomes for people with cancer and we will work to bring this new option to women in the EU, many of whom have historically poor outcomes, as quickly as possible.”

The EC approval was based on data from the pivotal Phase III SOLO-1 trial which tested Lynparza as maintenance monotherapy compared with placebo in patients with BRCAm advanced ovarian cancer following 1st-line platinum-based chemotherapy. Results announced in October 2018 at 40.7 months of follow-up showed the median time of progression for patients treated with Lynparza had not yet been reached vs. 13.8 months for those on placebo (HR 0.30 [95% CI, 0.23-0.41], p<0.001).