FDA Approves New Drug, Companion Test for Ovarian Cancer

By Amy Orciari Herman

Edited by André Sofair, MD, MPH

The FDA has approved olaparib capsules (brand name, Lynparza) — a poly ADP-ribose polymerase inhibitor — to treat women with advanced ovarian cancer associated with germline BRCA mutations.

At the same time, the agency approved BRACAnalysis CDx, a companion test to detect BRCA mutations and thus identify patients with ovarian cancer who may be eligible for olaparib treatment.

Olaparib's efficacy was studied in some 140 women who'd already received chemotherapy for advanced ovarian cancer associated with germline BRCA mutations. With olaparib treatment, roughly one-third of participants had shrinkage or complete disappearance of their tumor for about 8 months.