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Overview

PRIMA & PRIME showed how ZEJULA (niraparib) offers your patients a manageable safety and tolerability profile1–3

PRIMA
SAFETY PROFILE

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PRIME
SAFETY PROFILE

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Caution with direct comparison

Data from PRIME should be interpreted with the following caveats in mind:

  • The patient population in PRIME is different from the population enrolled in PRIMA
  • The study was conducted in Chinese patients
  • While the BGI HRD assay (BGI Genomics - Shenzhen, China) used in PRIME has received CE-IVDD approval, it has not been clinically validated
  • The ZEJULA capsule used in PRIME is independently manufactured by Zai Lab and has the same formulation composition as GSK’s ZEJULA capsule
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PRIMA study design

PRIME study design

PRIMA efficacy

PRIME efficacy

ZEJULA is indicated

  • 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.
  • 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.

Abbreviations

FIGO, Federation of Gynaecology and Obstetrics; HRD, homologous recombination deficiency.

References

  1. González-Martín A, et al. Poster presented at the European Society for Medical Oncology (ESMO) Congress; 9–13 September 2022. Poster 530.
  2. González-Martín A, et al. N Engl J Med. 2019;381(25):2391–2402.
  3. Li N, et al. Efficacy and Safety of Niraparib as Maintenance Treatment in Patients with Newly Diagnosed Advanced Ovarian Cancer Using an Individualized Starting Dose(PRIME Study): A Randomized, Double-blind, Placebo-controlled, Phase 3 Trial. Presented at Society of Gynecologic Oncology Congress; 18–21 March 2022, Phoenix,Arizona.

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk (UK) or search for MHRA Yellow Card in the Google Play or Apple App store. Adverse events should also be reported to GSK Limited on 0800 221 441 or by email at uksafety@gsk.com.

©2023 GSK Group of Companies or its licensor. Trademarks are the property of their respective owners.

June 2023 | PM-GB-NRP-WCNT-220021 (V1.0)