FDA Approves Ovarian Cancer Drug With Companion BRCA Diagnostic Test

The Food and Drug Administration Dec. 19 granted accelerated approval to Lynparza (olaparib) for the treatment of women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.

Lynparza, which is marketed by U.K.–based AstraZeneca, is a poly ADP-ribose polymerase (PARP) inhibitor that blocks enzymes involved in repairing damaged DNA, the agency said. It is intended for women with heavily pretreated ovarian cancer that is associated with defective BRCA genes.

“Today’s approval constitutes the first of a new class of drugs for treating ovarian cancer,” said Richard Pazdur, director of the Office of Hematology and ...