Niraparib: A Review in Ovarian Cancer
Niraparib (Zejula®), a poly (ADP-ribose) polymerase (PARP) inhibitor, is approved for the maintenance treatment of recurrent, epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who are in complete or partial response to platinum-based chemotherapy. Approval was based on the results of the randomized, double-blind, placebo-controlled phase III NOVA trial. In NOVA, niraparib significantly prolonged progression-free survival (primary endpoint), chemotherapy-free interval and time to first subsequent therapy compared with placebo in patients with recurrent, platinum-sensitive, high grade serous ovarian, fallopian tube or primary peritoneal cancer. The beneficial effects of niraparib were consistent regardless of BRCA mutation or homologous recombination deficiency (HRD) status. Niraparib had a manageable tolerability profile, with the majority of grade 3 or 4 adverse events being haematologic abnormalities (e.g. thrombocytopenia, anaemia, neutropenia). Adverse events were generally well managed with dose interruption or modification of niraparib. Current evidence suggests that niraparib is an effective new option with a manageable tolerability profile for the maintenance treatment of recurrent, platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults, with or without BRCA1/2 mutation or HRD.
During the peer review process, the manufacturer of niraparib was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
Compliance with Ethical Standards
The preparation of this review was not supported by any external funding.
Conflicts of Interest
Young-A Heo and Sean Duggan are salaried employees of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.
- 2.Labidi-Galy SI, Papp E, Hallberg D, et al. High grade serous ovarian carcinomas originate in the fallopian tube. Nat Commun. 2017; https://doi.org/10.1038/s41467-017-00962-1.
- 3.National Comprehensive Cancer Network. Ovarian cancer including fallopian tube cancer and primary peritoneal cancer (NCCN clinical practice guidelines in oncology). 2018. http://www.nccn.org/. Accessed 10 May 2018.
- 9.TESARO Inc. Zejula® (niraparib): US prescribing information 2017. http://www.fda.gov. Accessed 27 June 2018.
- 10.European Medicines Agency. Zejula (niraparib) 100 mg hard capsules: summary of product characteristics. 2018. http://www.ema.europa.eu/. Accessed 27 June 2018.
- 13.European Medicines Agency. Zejula: European Public Assessment Report 2017. http://www.ema.europa.eu/. Accessed 27 Dec 2017.
- 19.Berek JS, Matulonis UA, Peen U, et al. Safety and dose modification for patients receiving niraparib. Ann Oncol. 2018; https://doi.org/10.1093/annonc/mdy181.
- 21.Mahner S, Mirza MR, Moore K, et al. ENGOT-OV16/NOVA: results of secondary efficacy endpoints of niraparib maintenance therapy in ovarian cancer. Clin Adv Hematol Oncol. 2017;15(5 Suppl 5):2–3.Google Scholar
- 22.Fabbro M, Moore K, Dørum A, et al. Safety and efficacy of niraparib in elderly patients (pts) with recurrent ovarian cancer (OC) [abstract no. 934PD]. Ann Oncol. 2017;28(Suppl 5):v330–v54.Google Scholar
- 24.Ledermann J, Sessa C, Colombo N on behalf of the ESMO guidelines committee. eUpdate – ovarian cancer treatment recommendations 2016. http://www.esmo.org. Accessed 19 Mar 2018.
- 25.National Institue for Health and Care Excellence. Final appraisal determination: niraparib for maintenance treatment of relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer. 2018. http://www.nice.org.uk. Accessed 5 June 2018.