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ZEJULA (niraparib) is the only once-daily oral PARP inhibitor monotherapy approved for first-line platinum responders with advanced ovarian cancer regardless of biomarker status.1-2

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Extended PFS 
regardless of biomarker status vs placebo1

VIEW EFFICACY

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Manageable
safety and tolerability profile3

VIEW SAFETY

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Individualised starting dose
that can minimise AEs while maintaining efficacy*1,4-7

VIEW STARTING DOSE

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Convenient,
once-daily oral monotherapy1

VIEW DOSING

*This analysis is exploratory in nature and was not powered to detect a statistically significant treatment effect; therefore, results should be interpreted with caution.

ZEJULA indication

*Zejula is indicated for the maintenance treatment of adult patients with advanced high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy1

DISCOVER THE PRIMA CLINICAL TRIAL

ZEJULA is indicated:1

  • 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.

Footnotes

AE, adverse event; BRCA, breast cancer susceptibility gene; BRCAmut, BRCA mutation; BRCAwt, BRCA wild-type; CR, complete response; FIGO, International Federation of Gynecology and Obstetrics; GSK, GlaxoSmithKline; HRd, homologous recombination deficient; HRp, homologous recombination proficient; MoA, mechanism of action; PARP, poly(ADP-ribose) polymerase; PFS, progression-free survival; PLC, public limited company; PR, partial response; QoL, quality of life.

References

  1. Zejula Summary of Product Characteristics www.medicines.ie Last Accessed October 2023.
  2. Olaparib Summary of Product Characteristics www.medicines.ie Last Accessed October 2023.
  3. González-Martín A, Pothuri B, Vergote I, et al. N Engl J Med. 2019;381(25):2391–2402.
  4. Mirza MR, González-Martin A, Graybill WS, et al. Prospective evaluation of the tolerability and efficacy of niraparib dosing based on baseline body weight and platelet count: results from the PRIMA/ENGOT­ OV26/GOG-3012 trial. Cancer. 2023;1-10. doi:10.1002/ cncr. 34706.
  5. Korach J, Graybill W, Redondo A, et al. Niraparib in patients with newly diagnosed advanced ovarian BRCAm cancer: a post hoc analysis of the PRIMA/ENGOT-OV26/GOG-3012 trial. Abstract presented at the European Society of Gynaecological Oncology (ESGO) Congress; 14–16 December 2020. Abstract 571.
  6. GSK, Inc. Data on file. 2020 [list of adverse events by fixed versus individualised starting dose].
  7. GSK, Inc. Data on file. 2020 [Niraparib Global Data Sheet].

 

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

Zejula is a registered trademark of the GlaxoSmithKline group of companies.

December 2023  PM-IE-NRP-WCNT-220022