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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/04/01 | Phase 1 | Terminated | |||
2020/12/21 | Phase 3 | Completed | |||
2020/11/10 | Phase 2 | Completed | |||
2020/09/07 | N/A | Completed | Grupo Español de Investigación en Cáncer de Ovario | ||
2020/07/02 | Phase 3 | Active, not recruiting | |||
2020/02/19 | Phase 2 | Suspended | |||
2020/02/05 | Phase 1 | Active, not recruiting | |||
2020/01/13 | Phase 3 | Completed | |||
2019/12/24 | Phase 1 | Completed | |||
2019/11/27 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| pharmaand GmbH | 82154-0785 | ORAL | 300 mg in 1 1 | 9/30/2023 | |
| pharmaand GmbH | 82154-0784 | ORAL | 250 mg in 1 1 | 9/30/2023 | |
| pharmaand GmbH | 82154-0783 | ORAL | 200 mg in 1 1 | 9/30/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/23/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.