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Safety Overview

ZEJULA (niraparib) 1L monotherapy as a maintenance treatment demonstrated a manageable safety profile in two phase III clinical trials, PRIMA and PRIME1-3

For a full list of Adverse Events and Special Warnings and Precautions please click here to view the Summary of Product Characteristics for ZEJULA

PRIMA
SAFETY PROFILE

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PRIME
SAFETY PROFILE

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Caution with direct comparison

Direct comparisons across independent studies (e.g., PRIMA and PRIME) are invalid due to heterogeneity in trial populations.
Caution should be exercised in interpreting comparative data.

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 (niraparib) is indicated4

  • 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; 1L, First Line.

References

  1. Gonzàlez-Martín A, et al. N Engl J Med. 2019;381(25):2391–2402.
  2. Gonzàlez-Martín A, et al. Eur J Cancer. 2023;189:112908.
  3. Li N, et al. JAMA Oncol. 2023;9(9):1230–1237
  4. ZEJULA (niraparib) Summary of Product Characteristics. 2023. (Accessed May 2024).

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.

©2024 GSK Group of Companies or its licensor. Trademarks are the property of their respective owners.

May 2024 | PM-GB-NRP-WCNT-220021 (V2.0)