Rucaparib

(Rubraca®)

Rucaparib

Drug updated on 4/26/2024

Dosage FormTablet (oral; 200 mg, 250 mg, 300 mg)
Drug ClassPoly (ADP-ribose) polymerase (PARP) inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)- associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
  • Indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.

Latest News

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Summary
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  • Rucaparib (Rubraca) is indicated for the maintenance treatment of adult patients with a deleterious BRCA mutation-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Additionally, it is used for treating adult patients with a deleterious BRCA mutation-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and taxane-based chemotherapy.
  • Twelve systematic reviews/meta-analyses focused on comparing Rucaparib to other poly (ADP-ribose) polymerase inhibitors (PARPi), considering population types and subgroup considerations.
  • In mCRPC, Rucaparib has shown significant effectiveness, notably in patients carrying BRCA mutations. This includes improved survival metrics such as overall survival and progression-free survival, particularly among carriers of the BRCA2 mutation.
  • When compared to treatments like platinum therapy, PARP inhibitors demonstrated comparable PSA50 response rates and overall survival, indicating similar levels of effectiveness specifically within the group of mCRPC patients positive for BRCA mutations.
  • For ovarian cancer treatment, Rucaparib significantly improved progression-free survival, especially among those having germline or somatic type BRCA mutations along with homologous recombinant-deficient tumors. The benefits were observed across various subgroups, including both newly diagnosed cases as well as recurrent ones, irrespective of the presence of the mentioned genetic alterations.
  • While generally well-tolerated by most subjects, serious adverse events occurred at higher incidences when using these drugs than with placebo or non-PARPi therapies but could be managed through dose modifications or discontinuation where necessary.
  • Differences emerged regarding toxicity profiles among all PARP inhibitors studied; Olaparib caused fewer grade 3+ adverse events compared to Niraparib and Rucaparib in ovarian cancer treatment.
  • The effectiveness of PARP inhibitors, including Rucaparib, was particularly marked within patients carrying BRCA mutations and HRD tumors, highlighting the importance of genetic markers as predictive indicators for treatment response. Both somatic and germline mutation subsets showed similar benefits, indicating that both types of mutations are relevant targets for this therapy.

Product Monograph / Prescribing Information

Document TitleYearSource
Rubraca (rucaparib) Prescribing Information.2022FDA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
PARP inhibitors in metastatic prostate cancer: A comprehensive systematic review and meta-analysis of existing evidence.2024Clinical Genitourinary Cancer
PARP inhibitor era in ovarian cancer treatment: A systematic review and meta-analysis of randomized controlled trials.2024Journal of Ovarian Research
Poly (ADP-ribose) polymerase inhibitors have comparable efficacy with platinum chemotherapy in patients with BRCA-positive metastatic castration-resistant prostate cancer. A systematic review and meta-analysis.2023European Urology Oncology
Comparing efficacy of first-line treatment of metastatic castration resistant prostate cancer: A network meta-analysis of randomized controlled trials.2023Frontiers in Pharmacology
Comparative efficacy and safety of poly (ADP-ribose) polymerase inhibitors in patients with ovarian cancer: A systematic review and network meta-analysis.2022Frontiers in Oncology
The molecular mechanisms of actions, effects, and clinical implications of parp inhibitors in epithelial ovarian cancers: A systematic review.2022International Journal of Molecular Sciences
Comparative efficacy and safety of PARP inhibitors as maintenance therapy in platinum sensitive recurrent ovarian cancer: A network meta-analysis. 2021Frontiers in Oncology
Comparison of the efficacy and safety of PARP inhibitors as a monotherapy for platinum-sensitive recurrent ovarian cancer: A network meta-analysis.2021Frontiers in Oncology
Molecular and clinical predictors of improvement in progression-free survival with maintenance PARP inhibitor therapy in women with platinum-sensitive, recurrent ovarian cancer: A meta-analysis.2021Cancer
Evaluation of the efficacy and safety of PARP inhibitors in advanced-stage epithelial ovarian cancer.2020Frontiers in Oncology
Comparison of poly (ADP-ribose) polymerase inhibitors (PARPis) as maintenance therapy for platinum-sensitive ovarian cancer: Systematic review and network meta-analysis.2020Cancers
When and how to use parp inhibitors in prostate cancer: A systematic review of the literature with an update on on-going trials.2020European Urology Oncology

Clinical Practice Guidelines