Direct Healthcare Professional Communication (DHPC) on Rubraca®▼(rucaparib-camsylate): restriction of indication
2022.08.08
Active substance: rucaparib-camsylate
Clovis Oncology Ireland Ltd, in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that 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.
For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):
Download DHPC / Information letter , Download_VeroeffentlichtAm_EN