LYNPARZA? (olaparib) Tablets Receive EU Approval for the Treatment of Platinum-Sensitive Relapsed Ovarian Cancer

发布时间： 2018-05-28 阅读：777次

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The European Medicines Agency (EMA) has approved LYNPARZA? (olaparib) tablets (300 mg 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.

LYNPARZA, the first PARP inhibitor approved, was initially licensed in Europe as a capsule formulation for women with BRCA-mutated platinum-sensitive relapsed ovarian cancer. The new tablet formulation, which reduces dosing from eight capsules twice daily to two tablets twice daily, will now be available for a broader group of women with platinum-sensitive relapsed ovarian cancer.

Dave Fredrickson, executive vice president, 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-characterized safety and tolerability profile.”

Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck 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.”