AstraZeneca Plc - Lynparza receives positive EU CHMP opinion for 1st

AstraZeneca and MSD's Lynparza is the only PARP inhibitor to demonstrate an improvement in progression-free survival for patients in this setting

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today 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.

Dave Fredrickson, Executive Vice President, Oncology, said: "There remains a significant unmet need in the treatment of advanced ovarian cancer as 70% of women globally relapse within the first three years after their initial treatment. The results of SOLO-1 demonstrate the potential of using Lynparza earlier in the treatment pathway as a maintenance therapy, and reinforce the importance of identifying a patient's BRCAmutation status as soon as they are diagnosed."

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 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.

Lynparza is currently approved in 64 countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCAstatus. It is approved in the US as 1st-line maintenance treatment of BRCAm advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in 38 countries, including the US, countries in the EU and Japan, for germline BRCAm HER2-negative metastatic breast cancer previously treated with chemotherapy; in the EU this includes locally advanced breast cancer. Regulatory reviews are underway in other jurisdictions for both ovarian cancer and breast cancer.