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PRIMA study overview

PRIMA is a randomised, double-blind, placebo-controlled phase III trial1,2

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

SAFETY PROFILE

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PRIMA REPORTED TEAEs

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Monitoring and AE management

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PRIMA is a randomised, double-blind, placebo-controlled phase III trial1,2

A randomised, double-blind, placebo-controlled phase III trial1,3

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*HRD status assessed using the FDA-approved Myriad myChoice CDx as either BRCAm or GIS+ (GIS ≥42).1
†Exploratory and post hoc analyses.

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PRIMA efficacy

ZEJULA QoL

ZEJULA (niraparib) is indicated3

  • 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

AE, adverse event; BRCA, breast cancer susceptibility gene; BRCAmut, BRCA mutation; CR, complete response; FIGO, Federation of Gynaecology and Obstetrics; GIS, genomic instability score; HRD, homologous recombination deficiency; PFS, progression-free survival; PR, partial response; TEAE, treatment-emergent adverse event.

References

  1. Gonzalez-Martin A, et al, European Journal of Cancer, 189 (2023) 112908. doi:10.1016/j.ejca.2023.04.024
  2. González-Martín A, et al. N Engl J Med. 2019;381(25):2391–2402.
  3. Zejula (niraparib) Summary of product characteristics (Last 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)