EU approval for MSD and AZ’s Lynparza in first-line BRCA-mutated advanced ovarian cancer
pharmafile | June 18, 2019 | News story | Manufacturing and Production, Sales and Marketing | AstraZeneca, Cancer, MSD, lynparza, ovarian cancer, pharma
AstraZeneca and MSD’s jointly-developed therapy Lynparza (olaparib) has scored its third EU approval, the pair announced, with authorisation for the first-line treatment of female patients with BRCA-mutated advanced ovarian cancer.
Specifically, the authorisation covers the maintenance of FIGO Stages III and IV BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in those who are in response (complete or partial) following completion of 1st-line platinum-based chemotherapy.
Phase 3 data supporting the application showed that, after 40.7 months of treatment, Lynparza had not reached its median time of disease progression in patients, compared to the 13.8 months scored by placebo.
“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,” explained MSD’s Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer. “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.”
Dave Fredrickson, Executive Vice President, Oncology Business Unit at AstraZeneca, also remarked: “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.”
Matt Fellows
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