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.

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. Y.Y. Syed is a salaried employee of Adis, Springer SBM.

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Correspondence to Yahiya Y. Syed.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Syed, Y.Y. Rucaparib: First Global Approval. Drugs 77, 585–592 (2017). https://doi.org/10.1007/s40265-017-0716-2

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Keywords

  • Ovarian Cancer
  • Objective Response Rate
  • Advanced Ovarian Cancer
  • Royalty Payment
  • Homologous Recombination Deficiency