Lynparza Earns Priority Review for Advanced Ovarian Cancer
AstraZeneca and Merck earned priority review from the FDA for Lynparza (olaparib) in combination with bevacizumab for the maintenance treatment of women with advanced ovarian cancer whose disease showed a complete or partial response to first-line treatment with platinum-based chemotherapy and bevacizumab.
The supplemental NDA was based on the results of a phase 3 clinical trial, which showed that Lynparza added to bevacizumab reduced the risk of disease progression or death by 41 percent and improved progression-free survival to a median of 22.1 months versus 16.6 months for patients treated with bevacizumab alone.
The approval would be Lynparza’s fourth indication for ovarian cancer patients in the U.S. It was most recently approved as a first-line maintenance treatment for germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer that has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.