What is the role of rucaparib (Rubraca) in the treatment of ovarian cancer?

Updated: Aug 10, 2020
  • Author: Andrew E Green, MD; Chief Editor: Yukio Sonoda, MD  more...
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Answer

Rucaparib

The PARP inhibitor rucaparib gained accelerated approval by the FDA in December 2016. It is indicated for monotherapy of women with deleterious BRCA mutations (germline and/or somatic) associated with advanced ovarian cancer who have been treated with ≥2 prior lines of chemotherapy.

Approval was based results from 106 women enrolled in 2 single-arm clinical trials, Study 10 and ARIEL2 (Assessment of Rucaparib In Ovarian CancEr TriaL2). Patients in these trials had an overall response rate of 54% (complete, 9%; partial, 45%) and a median duration of response of 9.2 months, according to the FDA press materials. The drug's prescribing information also indicates that the overall response rate as assessed by an independent radiology review was 42%, with a median duration of response of 6.7 months, while the investigator-assessed response rate was 66%. [107, 108, 109]

Continued approval of rucaparib for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The ARIEL3 maintenance confirmatory study has completed enrollment and the ARIEL4 treatment confirmatory study is open for enrollment at the time of this update.


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