Rucaparib: First Global Approval

Rucaparib (Rubraca TM) is an oral, small molecule, poly (ADP-ribose) polymerase inhibitor being developed by Clovis Oncology, Inc. (Boulder, CO, USA) for the treatment of solid tumours. It has been approved in the USA as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/ or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies. A marketing authorization application for rucaparib for the same indication has been submitted to the European Medicines Agency. Rucaparib is also under phase II or III investigation in ovarian, breast and prostate cancer. This article summarizes the milestones in the development of rucaparib leading to this first approval for ovarian cancer.