Difference between revisions of "Niraparib (Zejula)"
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==General information== | ==General information== | ||
| − | Class/mechanism: PARP inhibitor. | + | 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 | ||
| − | 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 | + | *[https://www.guidetopharmacology.org/GRAC/LigandDisplayForward?ligandId=8275 IUPHAR/BPS] |
| + | |||
| + | 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> | ||
==Diseases for which it is established ''(work in progress)''== | ==Diseases for which it is established ''(work in progress)''== | ||
| Line 20: | Line 22: | ||
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | *2017-11-16: Initial marketing authorization as Zejula. | + | *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)'' |
| − | + | *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. | |
| + | ==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== | ==Also known as== | ||
| − | *'''Code name:''' | + | *'''Code name:''' MK-4827 |
*'''Brand name:''' Niranib, Zejula | *'''Brand name:''' Niranib, Zejula | ||
| Line 33: | Line 41: | ||
[[Category:Mutation-specific medications]] | [[Category:Mutation-specific medications]] | ||
| − | [[Category: | + | [[Category:PARP1 inhibitors]] |
| + | [[Category:PARP2 inhibitors]] | ||
[[Category:Ovarian cancer medications]] | [[Category:Ovarian cancer medications]] | ||
| Line 39: | Line 48: | ||
[[Category:EMA approved in 2017]] | [[Category:EMA approved in 2017]] | ||
[[Category:FDA approved in 2017]] | [[Category:FDA approved in 2017]] | ||
| + | [[Category:Health Canada approved in 2019]] | ||
| + | [[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
- 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. Zejula is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed 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)
- 2020-10-27: Extension of indication to include the use of Zejula as monotherapy for the maintenance treatment of adult patients with advanced 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.
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