Overview
Niraparib is an orally active poly (ADP-ribose) polymerase (PARP) inhibitor. By blocking the enzymes responsible for DNA repair, niraparib induces cytotoxicity in cancer cells. Niraparib is selective towards PARP-1 and PARP-2. First approved by the FDA on March 27, 2017, niraparib is used to treat epithelial ovarian, fallopian tube, or primary peritoneal cancer. Niraparib was approved by the European Commission on November 16, 2017 and by Health Canada on June 27, 2019.
Indication
Niraparib is indicated for the maintenance treatment of adult patients with advanced or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. In Canada and the US, niraparib is also available in a combination product with abiraterone, which is indicated with prednisone for the treatment of adults with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). In Canada, this combination product is also used with prednisolone and is reserved for patients who are asymptomatic or mildly symptomatic, and in whom chemotherapy is not clinically indicated.
Associated Conditions
- Advanced Epithelial Ovarian Cancer
- Advanced Primary Peritoneal Carcinoma
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Recurrent Epithelial Ovarian Cancer
- Recurrent Fallopian Tube Cancer
- Recurrent Primary Peritoneal Cancer
- Advanced Fallopian Tubes Cancer
Research Report
Report on Niraparib (Zejula®): A Comprehensive Oncological Drug Monograph
Executive Summary
Niraparib, marketed under the brand name Zejula®, is an orally bioavailable, once-daily small-molecule inhibitor of Poly (ADP-ribose) Polymerase (PARP) enzymes, specifically PARP-1 and PARP-2.[1] As a targeted therapy, its primary mechanism of action leverages the principle of synthetic lethality, proving most effective in tumors characterized by Homologous Recombination Deficiency (HRD), a state that includes, but is not limited to, germline or somatic mutations in the
BRCA1 and BRCA2 genes.[4] Niraparib has established a significant role in gynecologic oncology, primarily as a maintenance therapy for adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer following a response to platinum-based chemotherapy, in both the first-line and recurrent settings.[6]
The clinical development of Niraparib is defined by a compelling yet complex narrative. Pivotal clinical trials, most notably the PRIMA and NOVA studies, have consistently demonstrated a statistically significant and clinically meaningful benefit in Progression-Free Survival (PFS).[8] This robust effect on delaying disease progression formed the basis for its initial broad regulatory approvals. However, this efficacy is juxtaposed with a notable toxicity profile, dominated by hematologic adverse events such as thrombocytopenia, anemia, and neutropenia. This safety challenge prompted a paradigm shift in its administration, leading to the development and implementation of an individualized starting dose (ISD) based on patient weight and baseline platelet count to improve tolerability.[11]
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/04/15 | Phase 2 | Withdrawn | Ibrahim Halil Sahin | ||
2024/03/26 | Phase 1 | Not yet recruiting | Rohan Garje | ||
2024/03/20 | Phase 3 | Recruiting | |||
2024/02/14 | Phase 1 | Not yet recruiting | Armando Santoro, MD | ||
2024/02/01 | Phase 2 | Not yet recruiting | |||
2023/12/22 | Phase 2 | Recruiting | MedSIR | ||
2023/12/08 | Phase 1 | Withdrawn | Haider Mahdi | ||
2023/11/21 | Phase 2 | Recruiting | Peking University Cancer Hospital & Institute | ||
2023/10/17 | N/A | Completed | |||
2023/10/11 | Phase 1 | Recruiting |
FDA Drug Approvals
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EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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Health Canada Drug Approvals
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CIMA AEMPS Drug Approvals
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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| No UK EMC drug information found for this drug. | |||||
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