Understanding the Clinical Benefits of ZEJULA
ZEJULA demonstrated significant improvement in progression-free survival, regardless of BRCA status1
Women with recurrent ovarian, fallopian tube, or primary peritoneal cancer benefited from ZEJULA, regardless of BRCA mutation status1
*Efficacy analysis was based on a blinded central independent radiologic and clinical oncology review committee.
†Based on a stratified Cox proportional hazards model.
‡Based on a stratified log-rank test.
BRCA, breast cancer susceptibility gene; CI, confidence interval; gBRCAmut, germline BRCA mutated; HR, hazard ration; NR, not reached; non-gBRCAmut, not germline BRCA mutated; PFS, progression-free survival.
Niraparib is a recommended option within NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for the maintenance therapy of adult patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response after two or more lines of platinum-based chemotherapy, including the most recent line.2
ZEJULA Provided More Time Without Disease Progression, Across Patient Subgroups, Regardless of BRCA Status1,3
This analysis is exploratory in nature; it does not control for type 1 error and is not powered to determine treatment effect in any subgroup.4
Similar magnitude of benefit within key demographic and prognostic subgroups3,4
BRCA, breast cancer susceptibility gene; CI, confidence interval; CR, complete response; gBRCAmut, germline BRCA mutated; HR, hazard ratio; HRD, homologous recombination deficiency; n/a, not applicable; non-gBRCAmut, not germline BRCA mutated; PR, partial response.
References: 1. ZEJULA [package insert]. Waltham, MA: TESARO, Inc; 2017. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer v2.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed May 4, 2018. To view the most recent and complete version of the guideline, go online to NCCN.org. 3. Mirza MR, Monk BJ, Herrstedt J, et al; ENGOT-OV16/NOVA investigators. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375(22):2154-2164. 4. Data on file. TESARO, Inc.
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See the clinical rigor behind the pivotal trial design for ZEJULA
View PFS in the gBRCAmut & non-gBRCAmut cohorts
QUALITY OF LIFE
Learn about the impact of ZEJULA on quality of life
See the pivotal phase 3 trial publication