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ZEJULA overview banner
If she responds to chemotherapy, you respond with ZEJULA¹

Now approved for first-line maintenance1

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

Extends PARP inhibitor therapy to more women1–4

The only once-daily, oral, first-line maintenance therapy approved for platinum-responsive advanced ovarian cancer, regardless of biomarker status, including:1–3

  • HRd, BRCAmut
  • HRd, non-BRCAmut
  • HRp, non-BRCAmut

Proven efficacy regardless of biomarker status1,4

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A well-characterised safety profile1,4
 

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Convenient, once-daily, oral monotherapy1

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  • Understanding the biochemical properties of ZEJULA

    Preclinical studies suggest that achieving activity in non-BRCAmut tumours may require higher PARP inhibitor concentration5

    Biochemical properties graphic Biochemical properties graphic

    The unique biochemical properties of ZEJULA informed the inclusion of non-BRCAmut patients in the PRIMA study†1

    The clinical significance of in vitro studies is unknown. Mechanism-of-action statements are not meant to imply efficacy. Pharmacokinetics data presented are drawn from the respective product labels. Due to the clear differences that exist in clinical pharmacology among the PARP inhibitors and in the absence of head-to-head studies, comparisons of safety and efficacy data cannot be made and are not intended.

    *The concentration of ZEJULA and olaparib in the tumour, brain, and plasma was analysed using a BRCAwt OVC134 ovarian cancer patient-derived xenograft model with BALB/c nude mice.6 All mice were treated at the MTD (ZEJULA 50 mg/kg daily, olaparib 67 mg/kg twice daily) for 2 days, and samples were collected immediately following 2 days of treatment.6 The dose normalised tumour AUC0–24h was 5.19 μM.h/mg for ZEJULA and 0.33 μM.h/mg for olaparib.6

    The PRIMA study was a randomised, double-blind, placebo-controlled Phase III trial examining the efficacy and safety of ZEJULA as first-line maintenance therapy in patients with newly-diagnosed advanced ovarian cancer with a partial or complete response to platinum-based chemotherapy.4

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. 2020.
  2. Olaparib. Summary of Product Characteristics. 2019.
  3. Rucaparib. Summary of Product Characteristics. 2019.
  4. González-Martín A, Pothuri B, Vergote I, et al; for the PRIMA/ENGOT-OV26/GOG-3012 Investigators. N Engl J Med. 2019;381(25):2391–2402.
  5. Farmer H, McCabe N, Lord CJ, et al. Nature. 2005;434(7035):917–921.
  6. Sun K, Mikule K, Wang Z, et al. Oncotarget. 2018;9(98):37080–37096.

ZEJULA je registrovaný léčivý přípravek, jehož výdej je vázán na lékařský předpis a není dosud hrazen z prostředků veřejného zdravotního pojištění. O mimořádnou úhradu si lze zažádat dle § 16 zákona č. 48/1997 Sb., o veřejném zdravotním pojištění. Léčivý přípravek podléhá dalšímu sledování. Případná podezření na nežádoucí účinky prosím hlaste na cz.safety@gsk.com. Před předepsáním léku se, prosím, seznamte s úplnou informací o přípravku, kterou najdete v Souhrnu údajů o přípravku na www.gskkompendium.cz nebo se obraťte na společnost GlaxoSmithKline, s.r.o., Hvězdova 1734/2c, 140 00 Praha 4; e-mail: cz.info@gsk.com; www.gsk.cz.

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

Schváleno 02/2021 PM-CZ-NRP-WCNT-200003