Zejula Banner
If she responds to chemotherapy, you respond with Zejula¹

Now approved for first-line maintenance treatment regardless of biomarker status1

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.1*

*ZEJULA is indicated 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.

Proven efficacy regardless of biomarker status

Zejula significantly reduced the risk of progression or death in the BRCAmut HRd subgroup vs placebo.1,2

The BRCAmut subgroup was analysed using the adjusted Cox regression method and was not powered for full statistical analysis.

Zejula PRIMA PFS HRd BRCAmut Zejula PRIMA PFS HRd BRCAmut

Zejula significantly reduced the risk of progression or death in the BRCAwt HRd subgroup vs placebo.1,2

efficacy-graph-2 efficacy-graph-2

Zejula significantly reduced the risk of progression and death in the overall population vs placebo.1,2

Zejula PRIMA PFS Overall population Zejula PRIMA PFS Overall population

A safety and tolerability profile consistent with previous clinical trial experience1-3

88% of women in the overall population remained on Zejula therapy without discontinuations due to AEs1,2

Side effects can be managed with dose interruption and modification.

  • AEs led to dose interruptions and reduction in 80% of patients, most frequently from thrombocytopenia (56%), anaemia (33%), and neutropenia (20%).

Individualised Zejula dosing reduced haematological AEs and maintained PFS vs a fixed starting dose1, 4-6

  • For patients weighing <77 kg OR with a platelet count <150,000/ uL, the recommended dose is 200mg taken orally once daily.1
  • For patients weighing ≥77 kg AND a platelet count ≥150,000/uL, the recommended dose is 300 mg taken orally once daily.1

PRIMA- Impact of individualised dosing on adverse events5

efficacy-graph-3 efficacy-graph-3

*Includes thrombocytopenia and platelet count decreased.
†Includes anemia and hemoglobin decreased.
‡Includes neutropenia and neutrophil count decreased.

Convenient, once-daily oral dosing1

infographic-1 infographic-1

Starting dose for first-line maintenance therapy based on baseline weight and platelet count1

infographic-2 infographic-2

200mg is the recommended starting dose for patients with moderate hepatic impairment (regardless of bodyweight).1,7

SEE THE FULL PRIMA CLINICAL TRIAL DATA

clicking this link will take you to a site which is not owned by GSK

AUC, area under the curve; BRCA, breast cancer susceptibility gene; BRCAmut, BRCA-mutated; BRCAwt, BRCA wild-type; FIGO, International Federation of Gynaecology and Obstetrics; HRd, homologous recombination deficient; HRp, homologous recombination proficient; L, litres; MTD, maximum tolerated dose; PARP, poly(adenosine diphosphate [ADP]-ribose) polymerase; Vd/F, apparent volume of distribution.

References

  1. Zejula (niraparib). Summary of Product Characteristics
  2. Gonzales-Martin A, et al N. Engl J Med. 2019; 381: 2391-2402
  3. Mirza MR, et al. N Engl J Med. 2016; 375: 2154- 2164
  4. Gonzalez- Martin A, et al. N Engl J Med. 2019; 381: 2391- 2402. Supplementary appendix.
  5. Graybill W, et al. Presented at IGCS 2020, 10-13 Sept (virtual)
  6. Mirza M, et al. Presented at ASCO 2020, 29 May- 2 June
  7. GSK UK Data on File NP-GB-NRP-BRF-210003 June 2021

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.

© 2020 GSK Group of Companies or its licensor.
Trademarks are the property of their respective owners.

July 2021 | PM-GB-NRP-WCNT-210006