FDA Gives Priority Review to Lynparza as First-line Maintenance Therapy for Advanced Ovarian Cancer

FDA Gives Priority Review to Lynparza as First-line Maintenance Therapy for Advanced Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has agreed to review the use of Lynparza (olaparib) tablets as a maintenance treatment for women newly diagnosed with advanced ovarian cancer, Merck announced in a press release. The application, which is for women with BRCA mutations in complete or partial response after standard first-line platinum-based chemotherapy, received priority review status. A decision is expected in early 2019. Lynparza, a PARP enzyme inhibitor, acts by preventing cells from repairing their DNA errors. The faster division rate of these cancer cells makes them accumulate errors faster than healthy cells, causing their death. The therapy is particularly effective in cancers with mutations in DNA-repairing genes, such as BRCA1 and BRCA2. According to AstraZeneca and Merck — known as MSD outside the U.S. and Canada — this is the first time a PARP inhibitor was given regulatory consideration in the U.S. as first-line maintenance treatment for advanced ovarian cancer. If approved, this will be the fourth indication for Lynparza in the
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