Rubraca should no longer be used as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

A detrimental effect of rucaparib on overall survival (OS) compared with the chemotherapy control, has been observed within the final analysis of data from the phase 3 study CO-338-043 (ARIEL4) for treatment of patients with advanced, recurrent ovarian cancer (HR = 1.31 [95% CI: 1.00, 1.73]).

Ongoing treatment in this setting should be reconsidered and patients be informed of the latest data and recommendations.