Clovis Oncology Ireland Ltd, in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices would like to inform you, that a detrimental effect in terms of overall survival (OS) has been observed for rucaparib-camsylate compared to the chemotherapy-containing control following a planned interim analysis (IA) in the post-approval randomized controlled study CO-338-043 (ARIEL4). The European Medicines Agency (EMA) is performing a review of all available information to assess the impact of this information on the use of Rubraca® as monotherapy for the 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. While the review is ongoing, physicians are recommended not to start monotherapy treatment with Rubraca® in the above treatment indication.

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN 2022.05.06 PDF, 261KB, File is accessible