www.fdanews.com/articles/189691-fda-gives-another-go-ahead-for-cancer-drug-lynparza
FDA Gives Another Go-Ahead for Cancer Drug Lynparza
December 28, 2018
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.