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Niraparib

Generic Name
Niraparib
Brand Names
Zejula
Drug Type
Small Molecule
Chemical Formula
C19H20N4O
CAS Number
1038915-60-4
Unique Ingredient Identifier
HMC2H89N35
Background

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
Associated Therapies
Maintenance therapy

A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients

Phase 3
Terminated
Conditions
Neoplasms, Breast
BRCA2 Gene Mutation
Carcinoma of Breast
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
BRCA1 Gene Mutation
Ovarian Neoplasms
Interventions
Drug: Physician's choice
Drug: niraparib
First Posted Date
2013-07-23
Last Posted Date
2022-11-15
Lead Sponsor
Tesaro, Inc.
Target Recruit Count
216
Registration Number
NCT01905592
Locations
🇬🇧

GSK Investigational Site, Whitchurch, Cardiff, United Kingdom

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