The European Commission has approved AZ and MSD’s Lynparza (olaparib) as a first line maintenance treatment for women 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 following completion of first line platinum-based chemotherapy. Approval was based on data from the pivotal Phase III SOLO-1 trial which tested Lynparza versus placebo in patients with BRCAm advanced ovarian cancer following first line platinum-based chemotherapy.
EVP, Oncology Business, AstraZeneca, Dave Fredrickson, said: “This approval sets the stage for a new standard of care in the EU for women with ovarian cancer and a BRCA mutation. The goals of front-line therapy have always been long-term remission and even cure, yet currently 70% of patients relapse within three years of initial treatment. The progression-free survival benefit of Lynparza observed in SOLO-1 represents a major step forward in our ambition to help transform patient outcomes.”
“Phase III SOLO-1 data prompts EU approval for Lynparza for first line maintenance treatment of BRCA-mutated advanced ovarian cancer“
SVP and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, Roy Baynes, 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.”