Difference between revisions of "Niraparib (Zejula)"

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==General information==
 
==General information==
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Class/mechanism per the [https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=615263 NCI Drug Dictionary]: An inhibitor of poly (ADP-ribose) polymerase (PARP) with potential antineoplastic activity. PARP Inhibitor MK4827 inhibits PARP activity, enhancing the accumulation of DNA strand breaks and promoting genomic instability and apoptosis. The PARP family of proteins detect and repair single strand DNA breaks by the base-excision repair (BER) pathway. The specific PARP family member target for PARP inhibitor MK4827 is unknown.  
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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.<ref name="insert">[http://zejula.com/docs/Zejula_(niraparib)_Full_Prescribing_Information.pdf Niraparib (Zejula) package insert]</ref><ref>[[:File:Niraparib.pdf | Niraparib (Zejula) package insert (locally hosted backup)]]</ref><ref>[http://zejula.com/ Zejula manufacturer's website]</ref><ref>[https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=615263 NCI Drug Dictionary Niraparib entry]</ref>
 
<br>Route: PO
 
<br>Route: PO
 
<br>Extravasation: n/a
 
<br>Extravasation: n/a
  
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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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the package insert.
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*[https://www.guidetopharmacology.org/GRAC/LigandDisplayForward?ligandId=8275 IUPHAR/BPS]
  
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==Preliminary data==
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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, or the prescribing information.<ref name="insert"></ref>
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===[[Ovarian cancer]]===
 
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# Mirza MR, Monk BJ, Herrstedt J, Oza AM, Mahner S, Redondo A, Fabbro M, Ledermann JA, Lorusso D, Vergote I, Ben-Baruch NE, Marth C, Mądry R, Christensen RD, Berek JS, Dørum A, Tinker AV, du Bois A, González-Martín A, Follana P, Benigno B, Rosenberg P, Gilbert L, Rimel BJ, Buscema J, Balser JP, Agarwal S, Matulonis UA; ENGOT-OV16/NOVA Investigators. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer. N Engl J Med. 2016 Dec 1;375(22):2154-64. Epub 2016 Oct 7. [http://www.nejm.org/doi/full/10.1056/NEJMoa1611310 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/27717299 PubMed]
 
  
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==Diseases for which it is established ''(work in progress)''==
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*[[Ovarian cancer]]
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==Patient drug information==
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*[https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Zejula_Capsules/pdf/ZEJULA-CAPSULES-PI-PIL.PDF Niraparib (Zejula) package insert]<ref name="insert"></ref>
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==History of changes in FDA indication==
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===[[Ovarian cancer]] - '''PARTIALLY WITHDRAWN'''===
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*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)''
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*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)''
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**2022-09-14: Indication voluntarily withdrawn by the manufacturer; awaiting FDA withdrawal notice.
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*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>)''
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==History of changes in EMA indication==
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*2017-11-16: Initial marketing authorization as Zejula. Zejula is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed [[Ovarian cancer|high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer]] who are in response (complete or partial) to platinum-based chemotherapy. ''(Based on NOVA)''
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*2020-10-27: Extension of indication to include the use of Zejula as monotherapy for the maintenance treatment of adult patients with advanced [[Ovarian cancer|epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer]] who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
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==History of changes in Health Canada indication==
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*2019-06-27: Initial notice of compliance
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==History of changes in PMDA indication==
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*2020-09-29: Newly indicated for the maintenance treatment of [[ovarian cancer]] in patients who have received first chemotherapy.
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*2020-09-29: Newly indicated for the maintenance treatment of recurrent [[ovarian cancer]] in patients who are in a complete or partial response to platinum-based chemotherapy.
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*2020-09-29: Newly indicated for the treatment of homologous recombination deficiency (HRD)-positive recurrent [[ovarian cancer]] in patients who are in a complete or partial response to platinum-based chemotherapy.
 
==Also known as==
 
==Also known as==
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MK4827
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*'''Code name:''' MK-4827
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*'''Brand name:''' Niranib, Zejula
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==References==
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<references/>
  
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[[Category:Drug index]]
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[[Category:Drugs]]
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[[Category:Chemotherapy]]
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[[Category:Oral medications]]
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[[Category:Oral chemotherapy]]
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[[Category:Mutation-specific medications]]
  
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[[Category:Enzyme inhibitors]]
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[[Category:PARP1 inhibitors]]
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[[Category:PARP inhibitors]]
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[[Category:PARP2 inhibitors]]
  
 
[[Category:Ovarian cancer medications]]
 
[[Category:Ovarian cancer medications]]
  
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[[Category:Investigational]]
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[[Category:EMA approved in 2017]]
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[[Category:FDA approved in 2017]]
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[[Category:Health Canada approved in 2019]]
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[[Category:PMDA approved in 2020]]

Latest revision as of 00:14, 6 July 2024

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, 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

History of changes in EMA indication

History of changes in Health Canada indication

  • 2019-06-27: Initial notice of compliance

History of changes in PMDA indication

  • 2020-09-29: Newly indicated for the maintenance treatment of ovarian cancer in patients who have received first chemotherapy.
  • 2020-09-29: Newly indicated for the maintenance treatment of recurrent ovarian cancer in patients who are in a complete or partial response to platinum-based chemotherapy.
  • 2020-09-29: Newly indicated for the treatment of homologous recombination deficiency (HRD)-positive recurrent ovarian cancer in patients who are in a complete or partial response to platinum-based chemotherapy.

Also known as

  • Code name: MK-4827
  • Brand name: Niranib, Zejula

References

  1. ↑ 1.0 1.1 1.2 Niraparib (Zejula) package insert
  2. ↑ Niraparib (Zejula) package insert (locally hosted backup)
  3. ↑ Zejula manufacturer's website
  4. ↑ NCI Drug Dictionary Niraparib entry
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