AstraZeneca and MSD’s PARP inhibitor Lynparza (olaparib) has received a positive opinion at the European Medicines Agency’s (EMA) latest Committee for Medicinal Products for Human Use (CHMP) meeting.
The recommendation is for first-line maintenance treatment of BRCA-mutated advanced ovarian cancer patients who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
The decision 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% versus placebo.
Of those patients receiving Lynparza, 60.4% remained progression-free at 36 months vs. 26.9% of women in the placebo arm.
Roy Baynes, senior vice president and head of Global Clinical Development, chief medical officer, MSD Research Laboratories, said: “Women with advanced ovarian cancer need and deserve new treatment options. In the SOLO-1 trial, Lynparza demonstrated a significant progression-free survival benefit as maintenance treatment for patients with advanced BRCA-mutated ovarian cancer following response to first-line platinum-based chemotherapy.
"If approved, this expanded indication could change the way women in Europe with BRCA-mutated advanced ovarian cancer are treated.”
The treatment is currently approved in 64 countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA status.
Ovarian cancer is a leading cause of cancer death in women worldwide, with a five-year survival rate of just 19%. In 2018, there were over 295,000 new cases diagnosed and around 185,000 deaths.