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Pharmaceuticals / Submissions and Approvals

FDA Gives Another Go-Ahead for Cancer Drug Lynparza

Jan. 2, 2019

The FDA granted another approval for Lynparza (olaparib), clearing the AstraZeneca and Merck oncology drug for maintenance treatment of adults with BRCA-mutated advanced ovarian cancer.

The approval is for adult patients who have deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to first-line, platinum-based chemo.

The approval was based on positive results from a Phase 3 trial that saw Lynparza reduce the risk of disease progression or death in patients by 70 percent.

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