For your adult patients with platinum-responsive advanced ovarian cancer1

If she
Responds

To Chemotherapy

You
Respond

With Zejula1

Proven efficacy in 1L maintenance regardless of biomarker status1,2

ZEJULA is the only once-daily, oral, first-line maintenance monotherapy approved for advanced ovarian cancer in complete or partial response to platinum-based chemotherapy, regardless of biomarker status1,3,4

Proven efficacy in 1L maintenance regardless of biomarker status1,2

ZEJULA is the only once-daily, oral, first-line maintenance monotherapy approved for advanced ovarian cancer in complete or partial response to platinum-based chemotherapy, regardless of biomarker status1,3,4

Study Design: PRIMA, a randomized double-blind, placebo-controlled phase 3 trial, evaluated the safety and efficacy of ZEJULA in women (N=733) with newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer following CR or PR to first-line platinum-based chemotherapy. Patients were randomized 2:1 to receive ZEJULA or placebo once daily. The primary endpoint was progression-free survival (PFS) in patients who had tumors that were HRd and in those in the overall population, as determined on hierarchical testing. PFS was measured from time of randomization to time of disease progression or death. At the time of the PFS analysis, limited overall survival data were available with 11% deaths in the overall population.1,2

ZEJULA (niraparib) Significantly Improved PFS in Newly Diagnosed Patients Who Responded to Platinum-Based Chemotherapy, Regardless of Biomarker Status1,2

Median PFS in PRIMA clinical trial1,2:

Overall population, 13.8 months with ZEJULA (niraparib) vs. 8.2 months with placebo
HRd population, 21.9 months with ZEJULA (niraparib) vs. 10.4 months with placebo
Overall Population Chart
Overall Population Chart

The safety and tolerability profile is well characterized and consistent with previous clinical trial experience1,2 

12% of patients discontinued treatment with ZEJULA due to adverse events2,5

ARs resulting in discontinuation of ZEJULA in >1% of patients included thrombocytopenia (3.7%), anemia (1.9%), and nausea and neutropenia (1.2% each)

Adverse Reactions Reported in ≥10% of All Patients Receiving ZEJULA in PRIMA1

PRIMA adverse reactions chart
PRIMA adverse reactions chart

ASCO and NCCN Guidelines include niraparib (ZEJULA) as a recommended option6,7

NCCN guidelines

NCCN CLINICAL PRACTICE GUIDELINES IN ONCOLOGY (NCCN GUIDELINES®)

Recommended Therapy Option for Certain Patients With Advanced Ovarian Cancer6

NCCN Guidelines® recommend niraparib (ZEJULA), an oral, once-daily PARP inhibitor, as an option for:

  • Single-agent maintenance therapy in patients with advanced ovarian cancer who are in complete or partial response after surgery and 1L platinum-based chemotherapy*

*Not a recommended option if the patient has BRCA1/2 wild-type or unknown mutation status and had bevacizumab as part of primary treatment.

  • Single-agent maintenance therapy for patients with platinum-sensitive recurrent epithelial ovarian cancer who are in a complete or partial response after ≥2 lines of platinum-based chemotherapy, including the most recent line
  • Single-agent recurrence therapy for patients with ovarian cancer who have been treated with ≥3 prior chemotherapy regimens and whose cancer is associated with HRD defined by either 1) a deleterious or suspected deleterious BRCA mutation or 2) genomic instability and progression >6 months after response to the last platinum-based chemotherapy

NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way. To view the most recent and complete version of the guidelines, go online to NCCN.org.

ASCO guidelines

ASCO GUIDELINE ON PARP INHIBITORS IN THE MANAGEMENT OF OVARIAN CANCER

ZEJULA Is a Recommended Therapy Option for Certain Patients With Advanced Ovarian Cancer7

The ASCO Guideline recommends ZEJULA, an oral, once-daily PARP inhibitor, as an option across multiple settings7:

  • 1L maintenance: women with newly diagnosed stage III-IV EOC that is in CR/PR to 1L platinum-based chemotherapy should be offered PARPi maintenance therapy with niraparib (all women) for treatment of high-grade serous or endometrioid ovarian cancer†‡
  • 2L+ maintenance: niraparib maintenance is an option for patients with EOC who are PARPi-naïve and who have responded to platinum-based therapy regardless of BRCA mutation status

Recommendation applies to patients who are PARPi-naïve.

Excerpt of ASCO recommendation is shown; please consult the ASCO Guidelines for complete recommendations on the use of PARP inhibitors for the management of EOC, including other PARP inhibitors and other treatment lines. Please note that the ASCO Guidelines include information about niraparib that has not been approved by the FDA and/or is inconsistent with its prescribing information.

1L, first-line; 2L+, second-line or more; ALT, alanine transaminase; AR, adverse reaction; ASCO, American Society of Clinical Oncology; AST, aspartate transaminase; BRCA, breast cancer susceptibility gene; BRCA+, BRCA-mutated; BRCA–, not BRCA-mutated; CI, confidence interval; CR, complete response; EOC, epithelia ovarian, tubal, or primary peritoneal cancer; HR, hazard ratio; HRD, homologous recombination deficiency; HRd, homologous recombination deficient; HRp, homologous recombination proficient; NCCN, National Comprehensive Cancer Network; PARP, poly (ADP-ribose) polymerase; PARPi, poly (ADP-ribose) polymerase inhibitor; PFS, progression-free survival; PR, partial response.

Efficacy Data

View efficacy data for
all indications

SAFETY DATA

Learn about the safety
and tolerability of ZEJULA

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References: 1. ZEJULA (niraparib). Prescribing Information. GlaxoSmithKline; 2021. 2. González-Martín A, Pothuri B, Vergote I, et al; for the PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2019;381(25):‍2391-2402. 3. Lynparza (olaparib). Prescribing Information. AstraZeneca Pharmaceuticals LP; 2020. 4. Rubraca (rucaparib). Prescribing Information. Clovis Oncology, Inc; 2020. 5. González-Martín A, Pothuri B, Vergote I, et al; for the PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in patients with newly diagnosed advanced ovarian cancer [supplementary appendix]. N Engl J Med. 2019;381(25):‍2391-2402. 6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer v.2.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed October 14, 2020. To view the most recent and complete version of the guidelines, go online to NCCN.org. 7. Tew WP, Lacchetti C, Ellis A, et al. PARP inhibitors in the management of ovarian cancer: ASCO Guideline. J Clin Oncol. 2020;38. Published online August 13, 2020. doi:10.1200/JCO.20.01924.