Rucaparib

Overview

Rucaparib is an anticancer drug and poly (ADP-ribose) polymerase (PARP) inhibitor. PARP is an enzyme that plays an essential role in DNA repair. Rucaparib is proposed to work in several PARP-dependent and PARP-independent mechanisms of action; however, it causes a unique effect of synthetic lethality. By targeting the genetically-mutated cancer cells that lack a DNA repair mechanism, rucaparib causes cancer cell death and reduces tumour growth. Rucaparib was granted FDA Breakthrough Therapy designation in April 2015 and accelerated approval in December 2016. The drug was later approved by the European Commission in May 2018. It is currently used to treat recurrent ovarian and prostate cancer in adults.

Indication

Rucaparib is 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. Under accelerated approval by the FDA, rucaparib is also 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.

Associated Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Recurrent Epithelial Ovarian Cancer
Recurrent Fallopian Tube Cancer
Recurrent Primary Peritoneal Cancer

Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes	2019/11/21	NCT04171700	Phase 2	Terminated	pharmaand GmbH
Rucaparib Plus Ramucirumab With or Without Nivolumab in Advanced Gastric and Esophageal Adenocarcinoma	2019/06/21	NCT03995017	Phase 1	Active, not recruiting	University of Kansas Medical Center
A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Participants With a Solid Tumor (SEASTAR)	2019/06/20	NCT03992131	Phase 1	Terminated	pharmaand GmbH
Drug-Drug Interaction Study of Rucaparib, Rosuvastatin and Oral Contraceptives	2019/05/17	NCT03954366	Phase 1	Completed	pharmaand GmbH
Window of Opportunity Trial, PARP Inhibitor Rucaparib Affect on PD-L1 Expression in Triple Negative Breast Tumors	2019/04/11	NCT03911453	Early Phase 1	Completed	University of Arizona
Pan Tumor Rollover Study	2019/04/02	NCT03899155	Phase 2	Recruiting	Bristol-Myers Squibb
Rucaparib in Treating Patients With Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)	2019/02/19	NCT03845296	Phase 2	Completed	SWOG Cancer Research Network
A Study Evaluating the Safety, Pharmacokinetics and Efficacy of Ipatasertib Administered in Combination With Rucaparib in Participants With Advanced Breast, Ovarian Cancer, and Prostate Cancer.	2019/02/15	NCT03840200	Phase 1	Completed	Hoffmann-La Roche
A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)	2019/01/31	NCT03824704	Phase 2	Terminated	pharmaand GmbH
Rucaparib Maintenance Therapy in Advanced Cervical Cancer	2019/01/07	NCT03795272	Phase 2	Withdrawn	Nordic Society of Gynaecological Oncology - Clinical Trials Unit

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

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Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

PARP Inhibitors Show Promise in Ovarian Cancer Maintenance Therapy

3 years ago

• PARP inhibitors, particularly olaparib, niraparib and rucaparib, demonstrate efficacy as maintenance therapy for newly-diagnosed and recurrent platinum-sensitive epithelial ovarian cancer (EOC). • These inhibitors significantly improve progression-free survival (PFS), but their impact on overall survival (OS) remains uncertain due to immature data. • PARP inhibitors are associated with increased risk of serious adverse events, including hematological toxicities and fatigue, impacting patients' quality of life. • Further research is needed to clarify the role of PARP inhibitors in platinum-resistant disease and to optimize their use in specific patient subgroups.

Comparative Analysis of PARP Inhibitors in BRCA-Mutated Ovarian Cancer Shows Similar Efficacy and Toxicity

5 years ago

• A network meta-analysis of PARP inhibitors (PARPi) in BRCA-mutated ovarian cancer reveals no significant differences in efficacy among various regimens used in upfront or relapsed settings. • The study assesses the cost-effectiveness of PARPi regimens using the ASCO value framework, indicating similar clinical benefits, toxicity, and net health benefit across different treatments. • Results suggest that adding bevacizumab to olaparib increases the cost per unit net health benefit compared to olaparib monotherapy in upfront treatment. • Upfront PARPi regimens demonstrate lower toxicity scores compared to those used in the relapsed setting, providing insights into treatment selection.

PARP Inhibitors Show Similar Efficacy in BRCA-Mutated Ovarian Cancer, Cost-Effectiveness Varies

5 years ago

A network meta-analysis reveals no significant differences in efficacy among PARP inhibitor regimens for BRCA-mutated ovarian cancer patients in upfront or relapsed settings.

PARP Inhibitors Show Promise in Epithelial Ovarian and Breast Cancers with BRCA1/2 Mutations

10 years ago

PARP inhibitors have demonstrated efficacy in platinum-sensitive epithelial ovarian cancer, particularly in high-grade serous disease, and in breast cancer with BRCA1/2 mutations.

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