AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States 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 as a first-line maintenance treatment in BRCA-mutated advanced ovarian cancer.
The CHMP’s recommendation is for the use of LYNPARZA as monotherapy for the 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, AstraZeneca, 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 they reinforce the importance of identifying a patient’s BRCA mutation status as soon as they are diagnosed.”
Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck 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 EMA committee’s positive opinion is based on data from the Phase 3 SOLO-1 trial which showed that LYNPARZA reduced the risk of disease progression or death by 70% versus placebo following response to platinum-based chemotherapy (HR 0.30 [95% CI 0.23-0.41], p<0.001).
LYNPARZA is currently approved in over 64 countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA status. It is approved in the U.S. as first-line maintenance treatment in BRCAm advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in 38 countries, including the U.S., 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.
Source: Company Press Release