For US Healthcare Professionals

For US HCPs

Request Samples
Request Samples
Request Samples

Efficacy

ZEJULA: The Only FDA-approved PARP Inhibitor With Statistically Significant PFS Across HRD-positive Advanced Ovarian Cancer1-3,a,b

For patients with complete or partial response to first-line platinum-based chemotherapy1

aDefined by either a deleterious BRCA mutation, and/or genomic instability.1

bPRIMA: A double-blind, placebo-controlled phase 3 trial of patients with newly diagnosed advanced ovarian cancer who were randomized 2:1 to ZEJULA or placebo. PFS was the primary endpoint evaluated by BICR, per RECIST v1.1, in the primary analysis (13.8-month follow-up). Homologous recombination status was a stratification factor in PRIMA, and hierarchical testing was used to control for overall type 1 error. In the HRD-positive population (n = 373): mPFS with ZEJULA was 21.9 months (95% CI, 19.3-NE) vs 10.4 months (95% CI, 8.1-12.1) with placebo; 
HR, 0.43 (95% CI, 0.31-0.59, P<0.0001).1,4

PRIMA Study Design

    PRIMA enrolled a broad range of patients, including patients with poor prognoses who were at higher risk of progression1,4,9-12:

    Of patients in the HRD-positive population (n=373):

    PRIMA patient prognosis infographic

    65% of patients on placebo estimated to have progressed or died within 2 years after diagnosis4

    fStage III and IV disease with visible residual tumor (>0 cm) after primary debulking surgery.9

     

    The PRIMA population may be reflective of your clinical practice8

    SEE PRIMA POPULATION ABOVE

    Primary Analysis

    The PRIMA trial met its primary endpoint: ZEJULA more than doubled median PFS vs placebo in the HRD-positive population1,4

    PFS in the HRd population line graph

    Consistent efficacy observed across exploratory HRD-positive subgroups4,7,13,g

    BRCAwt and BRCAm subgroups graphic

    gExploratory subgroup analysis, not powered to detect a statistically significant treatment effect. Interpret results with caution.

    Final Analysis

    5-year PFS rate in HRD-positive population: More than doubled 5-year PFS rates observed with ZEJULA in HRD-positive population vs placebo5

    Exploratory PFS graph
      Events, n (%) Median PFS HR (95% CI)
    ZEJULA
     (n = 247)    		 150 (60.7) 24.5 months 0.51
    (0.40-0.66)
    Placebo
     (n = 126)    		 105 (83.3) 11.2 months

    hInterpret results with caution.

    • Not powered to detect a statistically significant treatment effect
    • 5-year PFS rates estimated from Kaplan-Meier curve, with median follow-up time of 6.2 years5
    • The probability of patients in the HRD-positive population to be alive and progression-free at 5 years was 35% in the ZEJULA arm vs 16% in the placebo arm5

    OS in HRD-positive population

    Overall survival, a key secondary endpoint, was evaluated in the HRD-positive population after 185 events were observed1,5

      Events, n (%) Median OS
    (95% CI)    		 HR
    (95% CI)
    ZEJULA
     (n = 247)    		 120 (48.6) 71.9 months
    (55.5-NE)    		 0.95
    (0.71-1.29)
    Placebo
     (n = 126)    		 65 (51.6) 69.8 months
    (51.6-NE)

    In the control arm, PRIMA patients on placebo received nearly 3-fold higher subsequent PARP inhibitor treatment (48.4%) compared to patients in the ZEJULA arm (15.8%).14

    ZEJULA was associated with long-term PFS outcomes for patients with HRD-positive ovarian cancer5

    Checklist icon

    Safety Profile

    See safety data in 1L maintenance1,4,5

    LEARN MORE
    Once daily icon

    Dosing

    One tablet, once daily1

    EXPLORE DOSING

    1L = first-line; BICR = blinded independent central review; BRCA = breast cancer susceptibility gene; BRCAm = BRCA-mutated; BRCAwt = BRCA wild type; CI = confidence interval; CR = complete response; ECOG = Eastern Cooperative Oncology Group; FDA = US Food and Drug Administration; FIGO = International Federation of Gynecology and Obstetrics; GIS = genomic instability score; HR = hazard ratio; HRD = homologous recombination deficient; mPFS = median PFS; NE = not estimated; OS = overall survival; PARP = poly (ADP-ribose) polymerase; PFS = progression-free survival; PR = partial response; RECIST = Response Evaluation Criteria in Solid Tumors; tBRCAm = tumor BRCA-mutated; ULN = upper limit of normal.

    INDICATION & IMPORTANT SAFETY INFORMATION

    INDICATION

    IMPORTANT SAFETY INFORMATION

    INDICATION

    ZEJULA (niraparib) is indicated:

    • for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) - positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability.

    IMPORTANT SAFETY INFORMATION

    Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), including cases with a fatal outcome, have been reported in patients who received ZEJULA. In PRIMA, of patients within the HRD-positive population, MDS/AML occurred in 8 out of 245 (3.3%) patients treated with ZEJULA, and in 3 out of 125 (2.4%) patients treated with placebo with a follow-up of 6.1 years. The duration of therapy with ZEJULA in patients who developed secondary MDS/cancer therapy-related AML varied from 5.5 months to 5 years. All patients who developed secondary MDS/cancer therapy-related AML had received previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy. For suspected MDS/AML or prolonged hematological toxicities, refer the patient to a hematologist for further evaluation. Discontinue ZEJULA if MDS/AML is confirmed.

     

    Hematologic adverse reactions (thrombocytopenia, anemia, neutropenia, and/or pancytopenia) have been reported in patients receiving ZEJULA. The overall incidence of Grade ≥3 thrombocytopenia, anemia, and neutropenia were reported, respectively, in 39%, 31%, and 21% of patients receiving ZEJULA in PRIMA. Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 4%, 2%, and 2% of patients in PRIMA. In patients who were administered a starting dose of ZEJULA based on baseline weight or platelet count in PRIMA, Grade ≥3 thrombocytopenia, anemia, and neutropenia were reported, respectively, in 22%, 23%, and 15% of patients receiving ZEJULA. Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 3%, 3%, and 2% of patients. Do not start ZEJULA until patients have recovered from hematological toxicity caused by prior chemotherapy (≤Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months, and periodically thereafter. If hematological toxicities do not resolve within 28 days following interruption, discontinue ZEJULA, and refer the patient to a hematologist for further investigations.

     

    Hypertension and cardiovascular effects have been reported in patients receiving ZEJULA. Grade 3-4 hypertension occurred in 6% of patients receiving ZEJULA vs 1% of patients receiving placebo in PRIMA, with no reported discontinuations. Monitor blood pressure and heart rate at least weekly for the first two months, then monthly for the first year, and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Manage hypertension with antihypertensive medications and adjustment of the ZEJULA dose if necessary.

     

    Posterior reversible encephalopathy syndrome (PRES) occurred in 0.1% of 2,165 patients treated with ZEJULA in clinical trials and has also been described in postmarketing reports. Monitor all patients for signs and symptoms of PRES, which include seizure, headache, altered mental status, visual disturbance, or cortical blindness, with or without associated hypertension. Diagnosis requires confirmation by brain imaging. If suspected, promptly discontinue ZEJULA and administer appropriate treatment. The safety of reinitiating ZEJULA is unknown.

     

    Embryo-fetal toxicity and lactation: Based on its mechanism of action, ZEJULA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months after receiving their final dose of ZEJULA. Because of the potential for serious adverse reactions from ZEJULA in breastfed infants, advise lactating women not to breastfeed during treatment with ZEJULA and for 1 month after receiving the last dose.

     

    First-line Maintenance Treatment of HRD-Positive Advanced Ovarian Cancer

    Most common adverse reactions (Grades 1-4) in ≥10% of all patients who received ZEJULA in PRIMA were thrombocytopenia (66%), anemia (65%), nausea (62%), fatigue (52%), musculoskeletal pain (46%), neutropenia (43%), constipation (40%), leukopenia (29%), headache (27%), insomnia (25%), vomiting (23%), dyspnea (21%), decreased appetite (20%), dizziness (20%), cough (20%), hypertension (20%), AST/ALT elevation (14%), acute kidney injury (13%), and anxiety (12%).

     

    Common lab abnormalities (Grades 1-4) in ≥25% of all patients who received ZEJULA in PRIMA included: decreased hemoglobin (85%), decreased leukocytes (72%), decreased platelets (71%), decreased neutrophils (64%), increased glucose (62%), decreased lymphocytes (55%), increased alkaline phosphatase (48%), increased creatinine (40%), decreased magnesium (39%), increased AST (35%), increased ALT (32%), and increased calcium (31%).

     

    Please see the full Prescribing Information for ZEJULA.

    To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or 1-888-825-5249 or
    FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    References

    1. ZEJULA (niraparib). Prescribing information. GSK; 2025.

    2. Lynparza (olaparib). Prescribing information. AstraZeneca Pharmaceuticals LP; 2025.

    3. Rubraca (rucaparib). Prescribing information. pharmaand GmbH; 2024.

    4. González-Martín A et al. N Engl J Med. 2019;381(25):2391-2402. doi:10.1056/NEJMoa1910962

    5. Monk BJ et al. Ann Oncol. 2024;35(11):981-992. doi:10.1016/j.annonc.2024.08.2241

    6. A study of niraparib (GSK3985771) maintenance treatment in participants with advanced ovarian cancer following response on front-line platinum-based chemotherapy. ClinicalTrials.gov identifier: NCT02655016. Updated October 2, 2024. Accessed October 1, 2025. https://clinicaltrials.gov/study/NCT02655016

    7. González-Martín A et al. [supplementary appendix] N Engl J Med. 2019;381(25):1-42. doi:10.1056/NEJMoa1910962 

    8. Rodrigues M et al. Poster presented at: European Society for Medical Oncology Congress; September 16-21, 2021; virtual.

    9. Data on File, GSK.

    10. Horowitz NS et al. J Clin Oncol. 2015;33(8):937-943. doi:10.1200/JCO.2014.56.3106

    11. Chang S-J et al. Gynecol Oncol. 2013;130(3):493-498. doi:10.1016/j.ygyno.2013.05.040

    12. Davis A, Tinker AV, Friedlander M. Gynecol Oncol. 2014;133(3):624-631. doi:10.1016/j.ygyno.2014.02.038

    13. Monk BJ et al. Presented at: Society of Gynecologic Oncology Annual Meeting on Women’s Cancer Webinar Series; March 28-31, 2020.

    14. Monk BJ et al. [supplementary appendix] Ann Oncol. 2024;35(11):981-992. doi:10.1016/jannonc.2024.08.2241

    Together with GSK Oncology logo

    If your patients need help paying for their medicines or want to learn about other patient access and reimbursement services, please visit this website or call 1-844-4GSK-ONC (1-844-447-5662).