Drug updated on 4/26/2024
| Dosage Form | Tablet (oral; 200 mg, 250 mg, 300 mg) |
| Drug Class | Poly (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.
Summary
- 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 Title | Year | Source |
|---|---|---|
| Rubraca (rucaparib) Prescribing Information. | 2022 | FDA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Newly diagnosed and relapsed epithelial ovarian cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. | 2023 | Annals of Oncology |
| Guidelines for management of treatment-emergent adverse events during rucaparib treatment of patients with metastatic castration-resistant prostate cancer. | 2022 | Cancer Management and Research |
| PARP inhibitors in the management of ovarian cancer: ASCO guideline. | 2021 | Journal of Clinical Oncology |
| FDA approval summary: Rucaparib for the treatment of patients with deleterious BRCA‐mutated metastatic castrate‐resistant prostate cancer. | 2020 | Society of Translational Oncology |
| Practical guidance for the management of side effects during rucaparib therapy in a multidisciplinary UK setting. | 2020 | Therapeutic Advances in Medical Oncology |