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niraparib (Zejula)
Indications:
- maintenance treatment for recurrent epithelial cancers*
- ovarian cancer [2,3]
- fallopian tube cancer
- primary peritoneal cancer [1]
- triple-negative breast cancer (HER2-, ER-, PR-) in combination with pembrolizumab [3]
* for patients with complete or partial response to platinum-based chemotherapy [1]
Contraindications:
- pregnancy
Dosage:
- 300 mg PO QD
- continue until disease progression or unacceptable toxicity
Adverse effects:
- anemia, thrombocytopenia, neutropenia or leukopenia
- bone marrow suppression, myelodysplastic syndrome
- palpitations
- dry mouth, mucositis, dysgeusia
- nausea, constipation, vomiting, abdominal pain, abdominal distension, diarrhea, dyspepsia
- fatigue, decreased appetite
- urinary tract infection
- increased serum transaminases
- myalgia, arthralgia
- headache, dizziness
- insomnia, anxiety
- dyspnea, cough
- rash
- hypertension, including hypertensive crisis
Mechanism of action:
- inhibits poly ADP-ribose polymerase
General
small inhibitory antineoplastic agent (ib drug)
PARP inhibitor
Database Correlations
PUBCHEM cid=24958200
References
- FDA News Release. March 27, 2017
FDA approves maintenance treatment for recurrent epithelial
ovarian, fallopian tube or primary peritoneal cancers.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm548948.htm
- Windle ML.
FDA New Drug and Biologic Approvals -- 2017 Year-in-Review
Medscape - Jan 11, 2018.
https://reference.medscape.com/viewarticle/890871
- U.S. Food and Drug Administration.
Novel Drug Approvals for 2017.
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm
- Mirza MR, Monk BJ, Herrstedt J et al
Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent
Ovarian Cancer.
N Engl J Med. 2016 Dec 1;375(22):2154-2164. Epub 2016 Oct 7.
PMID: 27717299 Free Article
- Fuerst ML with expert critique by Sumrall AL
Advanced TNBC: 'Durable Activity' for Niraparib + Pembrolizumab.
Also benefit for platinum-resistant/refractory ovarian cancer.
MedPage Today. ASCO Reading Room 06.21.2018
https://www.medpagetoday.com/reading-room/asco/immunotherapy/73611