29th Apr 2019 08:43
LONDON (Alliance News) - AstraZeneca PLC and Merck & Co have secured positive opinion for Lynparza as ovarian cancer treatment from the Committee for Medicinal Products for Human Use of the European Medicines Agency, the pharmaceutical companies jointly announced Monday.
The CHMP opinion is a scientific recommendation for marketing authorisation to the European Commission.
The CHMP recommendation is for the use of Lynparza tablets as a maintenance treatment of adult patients with advanced BRCA1/2-mutated high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in response following completion of first-line platinum-based chemotherapy.
The positive opinion was based upon data from the Phase III 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. Of those patients receiving Lynparza, 60.4% remained progression-free at 36 months versus. 26.9% of women in the placebo arm, the companies said.
Lynparza 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.
Shares in AstraZeneca were trading 0.9% higher at 5,847 pence each.
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