Difference between revisions of "Niraparib (Zejula)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
===[[Ovarian cancer]] - '''PARTIALLY WITHDRAWN'''=== | ===[[Ovarian cancer]] - '''PARTIALLY WITHDRAWN'''=== | ||
| − | * | + | *2017-03-27: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm548487.htm Initial approval] for the maintenance treatment of adult patients with recurrent [[ovarian cancer|epithelial ovarian, fallopian tube, or primary peritoneal cancer]] who are in complete or partial response to [[Regimen_classes#Platinum-based_regimen|platinum-based chemotherapy]]. ''(Based on NOVA)'' |
| − | *10 | + | *2019-10-23: Approved for patients with advanced [[ovarian cancer|ovarian, fallopian tube, or primary peritoneal cancer]] treated with three or more prior chemotherapy regimens and whose cancer is associated with [[Biomarkers#HRD|homologous recombination deficiency (HRD)-positive]] status. HRD is defined by either a deleterious or suspected deleterious [[Biomarkers#BRCA|BRCA]] [[Biomarkers#Alterations|mutation]], or [[Biomarkers#Genomic_instability|genomic instability]] in patients with disease progression greater than six months after response to the last [[Regimen_classes#Platinum-based_regimen|platinum-based chemotherapy]]. ''(Based on QUADRA)'' |
| − | ** | + | **2022-09-14: Indication voluntarily withdrawn by the manufacturer; awaiting FDA withdrawal notice. |
| − | * | + | *2020-04-29: Approved for the maintenance treatment of adult patients with advanced [[ovarian cancer|epithelial ovarian, fallopian tube, or primary peritoneal cancer]] who are in a complete or partial response to first-line platinum-based chemotherapy. ''(Based on PRIMA<sub>OV</sub>)'' |
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | *11 | + | *2017-11-16: Initial marketing authorization as Zejula. |
==Also known as== | ==Also known as== | ||
Revision as of 14:10, 7 May 2023
General information
Class/mechanism: PARP inhibitor. Niraparib inhibits poly(ADP-ribose) polymerase (PARP) enzymes PARP-1 and PARP-2, which are involved in DNA repair. Inhibiting PARP-1 and PARP-2 may result in formation of PARP-DNA complexes, DNA damage, apoptosis, and cell death. PARP proteins utilize base-excision repair (BER) to identify and repair single strand DNA breaks.[1][2][3][4]
Route: PO
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is established (work in progress)
Patient drug information
History of changes in FDA indication
Ovarian cancer - PARTIALLY WITHDRAWN
- 2017-03-27: Initial approval for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. (Based on NOVA)
- 2019-10-23: Approved for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status. HRD is defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability in patients with disease progression greater than six months after response to the last platinum-based chemotherapy. (Based on QUADRA)
- 2022-09-14: Indication voluntarily withdrawn by the manufacturer; awaiting FDA withdrawal notice.
- 2020-04-29: Approved for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. (Based on PRIMAOV)
History of changes in EMA indication
- 2017-11-16: Initial marketing authorization as Zejula.
Also known as
- Code name: MK4827
- Brand name: Niranib, Zejula