FDA Approves Olaparib to Treat BRCA-Mutated Advanced Ovarian Cancer
- FLASCO
- March 10, 2015
- Drugs
FDA Approves Olaparib to Treat BRCA-Mutated Advanced Ovarian Cancer
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to olaparib (Lynparza) for women with advanced ovarian cancer with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, as detected by an FDA-approved test, who have been treated with three or more prior lines of chemotherapy. The FDA concurrently approved a companion diagnostic, BRACAnalysis CDx, for the qualitative detection and classification of variants in the BRCA1 and BRCA2 genes.
