title: Rucaparib: First Global Approval.
abstract: Rucaparib (Rubraca™) 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.
authors.affiliation: Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.
authors.forename: Yahiya Y
authors.initials: YY
authors.lastname: Syed
mesh_terms: D019313:BRCA1 Protein / Q000235:genetics; D024682:BRCA2 Protein / Q000235:genetics; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D017277:Drug Approval; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use*; D015394:Molecular Structure; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000235:genetics; D000067856:Poly(ADP-ribose) Polymerase Inhibitors / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use*
chemical_list: D019313:BRCA1 Protein; C492913:BRCA1 protein, human; D024682:BRCA2 Protein; C551750:BRCA2 protein, human; D007211:Indoles; D000067856:Poly(ADP-ribose) Polymerase Inhibitors; C531549:rucaparib