AstraZeneca, Merck ovarian cancer drug gets regulatory nod in EU
StockMarketWire.com - AstraZeneca and Merck said the European Commission had approved ovarian cancer drug as a front-line therapy following positive clinical trial results.
The European Commission approval was based on data from the pivotal Phase III SOLO-1 trial which tested the cancer drug, Lynparza, as maintenance monotherapy compared with placebo in patients with advanced ovarian cancer following 1st-line platinum-based chemotherapy.
The Phase III SOLO-1 trial showed that 60% of patients receiving the cancer drug Lynparza remained free of disease progression after three years compared with just 27% on placebo.
This approval sets the stage for a new standard of care in the EU for women with ovarian cancer and a BRCA mutation,' said Dave Fredrickson, Executive Vice President, Oncology Business Unit.
'SOLO-1, Lynparza demonstrated clinically-meaningful results with a 70% reduction in the risk of disease progression or death in the first-line maintenance treatment of patients with BRCAm advanced ovarian cancer,' said Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories.
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