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Rucaparib: First Global Approval

机译:Rucaparib:第一个全球批准

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摘要

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.
机译:Rucaparib(Rubraca TM)是由Clovis oncology,Inc。(Boulder,Co,USA)开发的口服,小分子聚合酶抑制剂,用于治疗实体肿瘤。 它已在美国批准作为治疗有害BRCA突变(种系和/或体细胞)相关的晚期卵巢癌的单一疗法,这些晚期卵巢癌已被两种或更多种化学疗法治疗。 对于相同指示的Rucaparib的营销授权申请已提交给欧洲药物局。 Rucaparib也在卵巢,乳腺癌和前列腺癌中的II期或III调查下。 本文总结了Rucaparib发展的里程碑,导致这对卵巢癌的第一次批准。

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