AZ and MSD's Lynparza secures CHMP nod in first-line BRCA-mutated ovarian cancer

AstraZeneca and MSD’s Lynparza (olaparib) has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP), it has emerged, as a first-line maintenance treatment of BRCA-mutated advanced ovarian cancer.

Specifically, the recommendation covers the use of the drug as a maintenance treatment for adult patients advanced 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.

According to the manufacturers, the decision makes Lynparza the only PARP inhibitor to improve progression-free survival in this indication. Data drawn from a Phase 3 study showed that the drug reduced the risk of disease progression or death by 70% compared to placebo after responding to platinum-based chemotherapy, with 60.4% remaining so at 36 months, compared to just 26.9 months.

“Women with advanced ovarian cancer need and deserve new treatment options,” commented Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer at MSD. “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.”

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 BRCA mutation status as soon as they are diagnosed.”

Matt Fellows