AstraZeneca and Merck announced that the European Commission approved Lynparza as a 1st-line maintenance treatment for women with a typof advanceded ovarian cancer.
Dave Fredrickson, executive vice president, oncology business unit, said: “This approval sets the stage for a new standard of care in the EU for women with ovarian cancer and a BRCA mutation. The goals of front-line therapy have always been long-term remission and even cure, yet currently, 70 percent of patients relapse within three years of initial treatment. The progression-free survival benefit of Lynparza observed in SOLO-1 (trial) represents a major step forward in our ambition to help transform patient outcomes.”
The EC approval was based on data from the pivotal Phase III SOLO-1 trial which tested Lynparza as maintenance monotherapy compared with placebo in patients with BRCAm advanced ovarian cancer following 1st-line platinum-based chemotherapy.
Results announced in October 2018 at 40.7 months of follow-up showed the median time of progression for patients treated with Lynparza had not yet been reached vs. 13.8 months for those on placebo.
AstraZeneca and Merck are exploring additional trials in ovarian cancer,.
Under the oncology collaboration with MSD (Merck) and following this new approval for Lynparza, AstraZeneca will receive $30 million in revenue.
Ovarian cancer is a leading cause of cancer deaths in women worldwide, with a five-year survival rate of 19 percent. In 2018, there were nearly 300,000 new cases diagnosed and around 185,000 deaths.
