Rucaparib

(Rubraca®)

Rubraca®

Drug updated on 12/11/2024

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.

Latest News

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Summary
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  • This summary is based on the review of 24 systematic review(s)/meta-analysis(es). [1-24]
  • General Effectiveness of Poly ADP-Ribose Polymerase (PARP) Inhibitors: In ovarian cancer patients, PARP inhibitors, including rucaparib, significantly improve progression-free survival (PFS), overall survival (OS), chemotherapy-free interval (CFI), time to first subsequent therapy or death (TFST), and time to second subsequent therapy or death (TSST) compared to placebo. In recurrent ovarian cancer with Breast Cancer Gene 1/2 (BRCA) mutations, rucaparib has shown an objective response rate (ORR) of 0.331.
  • Comparative Effectiveness in Ovarian and Prostate Cancer: For BRCA-mutated ovarian cancer, rucaparib, olaparib, and niraparib all demonstrated significant PFS improvements compared to placebo. In metastatic castration-resistant prostate cancer (mCRPC), rucaparib shows comparable efficacy to other PARP inhibitors, such as olaparib, niraparib, and talazoparib, in improving radiographic progression-free survival (rPFS) and OS.
  • Subgroup Effectiveness in BRCA and homologous recombination deficiency (HRD) Patients: Rucaparib is particularly effective in BRCA-mutated ovarian cancer and prostate cancer patients, and PARP inhibitors, including rucaparib, show improved PFS in HRD-positive ovarian cancer patients.
  • Newly Diagnosed vs. Recurrent Cancer Efficacy: PARP inhibitors, including rucaparib, demonstrate effectiveness in both newly diagnosed and recurrent ovarian cancer cases, with specific improvements noted in BRCA-mutated and HRD-positive populations.
  • General Safety of Rucaparib: In ovarian and prostate cancer treatments, rucaparib resulted in treatment-emergent adverse events (TEAEs) in 98.7% of patients, with 61% experiencing grade ≥3 events. Common adverse events included nausea, fatigue, vomiting, constipation, anemia, thrombocytopenia, elevated AST/ALT, and increased serum creatinine levels, with hematological toxicities, such as anemia, thrombocytopenia, and neutropenia, being particularly notable.
  • Comparative Safety in Ovarian Cancer: In ovarian cancer, olaparib had fewer grade ≥3 adverse events compared to rucaparib and niraparib, with rucaparib and niraparib showing higher incidences of grade 3-4 toxicities. In metastatic castration-resistant prostate cancer (mCRPC), rucaparib’s safety profile was comparable to other PARP inhibitors, although hematological adverse events occurred more frequently with PARP inhibitors than with non-PARPi treatments.
  • Rucaparib shows higher efficacy in ovarian and prostate cancer patients with BRCA mutations or HRD, with particularly beneficial outcomes in BRCA-mutated ovarian cancer and HRR-mutated mCRPC. Combination therapies with androgen receptor-targeted agents (ARTA) in prostate cancer enhance efficacy but may also increase the risk of adverse events.

Product Monograph / Prescribing Information

Document TitleYearSource
Rubraca (rucaparib) Prescribing Information.2023pharmaand GmbH, Vienna, Austria

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of PARP inhibitor maintenance therapy for ovarian cancer: a meta-analysis and trial sequential analysis of randomized controlled trials2024Frontiers in Pharmacology
Efficacy and safety of rucaparib in patients with recurrent high-grade ovarian carcinoma: A systematic review and meta-analysis2024Taiwanese Journal of Obstetrics & Gynecology
Efficacy and safety of PARP inhibitors in the treatment of prostatic cancer: a systematic review and network meta-analysis2024Chinese Clinical Oncology
The efficacy and safety of PARP inhibitors in mCRPC with HRR mutation in second-line treatment: a systematic review and bayesian network meta-analysis2024BMC Cancer
PARP inhibitor era in ovarian cancer treatment: a systematic review and meta-analysis of randomized controlled trials2024Journal of Ovarian Research
Hematological Toxicity of PARP Inhibitors in Metastatic Prostate Cancer Patients with Mutations of BRCA or HRR Genes: A Systematic Review and Safety Meta-analysis2024Targeted Oncology
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-analysis2024European Urology Oncology
Comparing efficacy of first-line treatment of metastatic castration resistant prostate cancer: a network meta-analysis of randomized controlled trials2023Frontiers in Pharmacology
Hematological Toxicities with PARP Inhibitors in Prostate Cancer: A Systematic Review and Meta-Analysis of Phase II/III Randomized Controlled Trials2023Cancers
Incidence and risk of hypertension associated with PARP inhibitors in cancer patients: a systematic review and meta-analysis2023BMC Cancer
The Molecular Mechanisms of Actions, Effects, and Clinical Implications of PARP Inhibitors in Epithelial Ovarian Cancers: A Systematic Review2022International Journal of Molecular Sciences
Comparative Efficacy and Safety of Poly (ADP-Ribose) Polymerase Inhibitors in Patients With Ovarian Cancer: A Systematic Review and Network Meta-Analysis2022Frontiers in Oncology
Comparison of the Efficacy and Safety of PARP Inhibitors as a Monotherapy for Platinum-Sensitive Recurrent Ovarian Cancer: A Network Meta-Analysis2021Frontiers in Oncology
Comparative safety and tolerability of approved PARP inhibitors in cancer: A systematic review and network meta-analysis2021Pharmacological Research
Poly (ADP-ribose) polymerase inhibitors in solid tumours: Systematic review and meta-analysis2021European Journal of Cancer
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-analysis2021Cancer
Comparative Efficacy and Safety of PARP Inhibitors as Maintenance Therapy in Platinum Sensitive Recurrent Ovarian Cancer: A Network Meta-Analysis2020Frontiers in Oncology
Comparison of Poly (ADP-ribose) Polymerase Inhibitors (PARPis) as Maintenance Therapy for Platinum-Sensitive Ovarian Cancer: Systematic Review and Network Meta-Analysis2020Cancers
Poly (ADP-ribose) polymerase (PARP) inhibitor regimens for ovarian cancer in phase III randomized controlled trials: a network meta-analysis2020International Journal of Gynecological Cancer
When and How to Use PARP Inhibitors in Prostate Cancer: A Systematic Review of the Literature with an Update on On-Going Trials2020European Urology Oncology
Evaluation of the Efficacy and Safety of PARP Inhibitors in Advanced-Stage Epithelial Ovarian Cancer2020Frontiers in Oncology
Real-world evidence of poly ADP-ribose polymerase inhibitors in the treatment of ovarian cancer: A systematic literature review2020Journal of Oncology Pharmacy Practice
Incorporating Parp-inhibitors in Primary and Recurrent Ovarian Cancer: A Meta-analysis of 12 phase II/III randomized controlled trials2020Cancer Treatment Reviews
PARP inhibitors as a new therapeutic option in metastatic prostate cancer: a systematic review2020Prostate Cancer and Prostatic Diseases

Clinical Practice Guidelines