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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.1-3

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Extended PFS 
regardless of biomarker status vs placebo1

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Manageable
safety and tolerability profile4

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Individualised starting dose
that can minimise AEs while maintaining efficacy*1,5-8

VIEW STARTING DOSE

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Convenient,
once-daily oral monotherapy1

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*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

Advanced ovarian cancer patients are eligible for first-line maintenance therapy with ZEJULA if they achieved PR or CR at the end of first-line platinum-based chemotherapy†, regardless of surgical outcome or biomarker status‡1

The graph below shows approximate distribution of biomarker status across eligible ovarian cancer patients.

Infographic showing overall population of biomarker status in ovarian cancer patients

†First-line treatment may be given as neoadjuvant chemotherapy with interval debulking surgery.
‡Figure adapted from Konstantinopoulos PA, et al. Cancer Discov. 2015;5: 1137-53.9

DISCOVER THE PRIMA CLINICAL TRIAL

ZEJULA reimbursement

Infographic of where ZEJULA ▼ (niraparib) fits into treatment pathway Infographic of where ZEJULA ▼ (niraparib) fits into treatment pathway

First-line chemotherapy may be given as neoadjuvant chemotherapy with interval debulking surgery.10,11 Figure for illustrative purposes.

England, Wales and Northern Ireland flags

ZEJULA is available in England, Wales and Northern Ireland through the Cancer Drugs Fund.10

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ZEJULA is accepted for use by the Scottish Medicine Consortium within NHS Scotland. 11

Frequently asked questions

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; NHS, National Health Service; 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.
  2. Olaparib Summary of Product Characteristics.
  3. Rucaparib▼ Summary of Product Characteristics.
  4. González-Martín A, Pothuri B, Vergote I, et al. N Engl J Med. 2019;381(25):2391–2402.
  5. Mirza MR, González-Martín A, Graybill W, et al. Evaluation of an individualized starting dose of niraparib in the PRIMA/ENGOT-OV26/GOG-3012 Study. Poster presented at the American Society of Clinical Oncology (ASCO) Congress; 29–31 May 2020. Poster 221.
  6. 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.
  7. GSK, Inc. Data on file. 2020 [list of adverse events by fixed versus individualised starting dose].
  8. GSK, Inc. Data on file. 2020 [Niraparib Global Data Sheet].
  9. Konstantinopoulos PA,et al. Cancer Discov. 2015;5:1137-54.
  10. NICE. Niraparib for maintenance treatment of advanced ovarian, fallopian tube and peritoneal cancer after response to first-line platinum-based chemotherapy. Available at https://www.nice.org.uk/guidance/ta673/resources/niraparib-for-maintenance-treatment-of-advancedovarian-fallopian-tube-and-peritoneal-cancer-after-response-to-firstlineplatinumbasedchemotherapy-pdf-82609317907909. Accessed January 2022.
  11. Scottish Medicines Consortium. SMC Advice on new medicines. Niraparib 100mg hard capsules (Zejula). Available at https://www.scottishmedicines.org.uk/media/5941/niraparib-zejula-final-april-2020-amended-4521docx-for-website.pdf. Accessed January 2022.

Adverse events should be reported.
Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store.

Adverse events should also be reported to GlaxoSmithKline on 0800 221 441.

© 2022 GSK Group of Companies or its licensor. Trademarks are the property of their respective owners.

March 2022 | PM-GB-NRP-WCNT-210016 (V1.0)

February 2022 | PM-GB-NRP-WCNT-210016 v1.0