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AstraZeneca & Merck’s Lynparza tablets receive EU approval

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For the treatment of platinum-sensitive relapsed ovarian cancer

AstraZeneca and Merck (known as MSD outside the US and Canada) announced that the European Medicines Agency (EMA) has approved Lynparza (olaparib) tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, regardless of BRCA status.

Dave Fredrickson, Executive VP, Head of the Oncology Business Unit at AstraZeneca, said, “With this new approval for Lynparza, we will now be able to offer more women with platinum-sensitive ovarian cancer, regardless of their BRCA status, a chance to achieve long-term disease control with an oral medicine that has a well-characterised safety and tolerability profile.”

Roy Baynes, Senior VP and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said, “This is an important development for the thousands of women in Europe living with advanced ovarian cancer, historically a difficult-to-treat disease. Working with AstraZeneca, we are able to bring this innovative, targeted treatment that helps delay progression of the disease to a broader group of women.”

The EU approval was based on two randomised trials, SOLO-2 and Study 19, which showed that Lynparza reduced the risk of disease progression or death for platinum-sensitive relapsed ovarian cancer patients compared to placebo.

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