Now FDA approved as first-line maintenance treatment of advanced ovarian cancer after response to chemotherapy1
In the PRIMA trial, ZEJULA offered more time without cancer recurring, regardless of certain genetic characteristics1,2:
The PRIMA clinical trial included 733 women with advanced ovarian cancer who responded to first-line platinum-based chemotherapy. The trial included women with and without a positive test result for certain genetic characteristics (ie, homologous recombination deficiency, or HRD). The HRD-positive group included women who were BRCA
-positive. The trial measured median progression-free survival, or mPFS. PFS means the length of time during and after treatment that you live with cancer but it does not get worse. Median is the middle number in a set of data, also called the midpoint. It means that half of the numbers are greater than the median and half are less.1-5
Overall study population (733 women)1
HRD-positive group (373 women)1
Women taking ZEJULA had less risk of disease progression1,2
In the overall study population, ZEJULA reduced the risk of progression by 38% compared with placebo
In HRD-positive women, ZEJULA reduced the risk of progression by 57% compared with placebo
ZEJULA is approved for women with and without a positive test for BRCA or HRD1,2
The safety profile of ZEJULA in the PRIMA trial was consistent with the NOVA and QUADRA clinical trials that studied ZEJULA.1,2
The most common adverse reactions in PRIMA included low red blood cells, low platelets, low white blood cells, nausea, vomiting, constipation, tiredness, changes in liver function and other blood tests, decreased appetite, pain in the joints, muscles, and back, headache, dizziness, trouble sleeping, changes in the amount or color of the urine, shortness of breath, cough, and high blood pressure. Due to an adverse reaction, 12% of women stopped treatment with ZEJULA and 2.5% stopped treatment with placebo. These are not the only side effects associated with ZEJULA.
References: 1. ZEJULA (niraparib) Prescribing Information. GlaxoSmithKline; 2020. 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. Frey MK, Pothuri B. Homologous recombination deficiency (HRD) testing in ovarian cancer clinical practice: a review of the literature. Gynecol Oncol Res Pract. 2017;4:4. doi:10.1186/s40661-017-0039-8. 4. NCI Dictionary of Cancer Terms: progression-free survival. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/progression-free-survival. Accessed January 8, 2020. 5. Median. Merriam-Webster website. https://www.merriam-webster.com/dictionary/median. Accessed March 18, 2020.
The information on this page pertains to the maintenance therapy indication for ZEJULA.
With ZEJULA, You May Have a Choice About What Comes Next in Your Ovarian Cancer Treatment
ZEJULA is a once-daily, oral medicine used for the maintenance treatment of women with recurrent ovarian, fallopian tube, or primary peritoneal cancer that comes back.
ZEJULA is the first and only once-daily PARP inhibitor used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy.1-3
See below for full Indication.
In a study of ZEJULA as Maintenance Treatment for Recurrent Ovarian Cancer
ZEJULA offered nearly
median time in response to chemotherapy for women with recurrent ovarian cancer with an inherited BRCA mutation vs watch and wait (placebo)1,4
median time in response to chemotherapy for women with recurrent ovarian cancer without an inherited BRCA mutation vs watch and wait (placebo)1,4
In the NOVA trial, ZEJULA was evaluated as a maintenance treatment in a double-blind, placebo-controlled phase 3 trial of 553 women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who1‡
- Received at least 2 platinum-based chemotherapy treatments, and
- Had a complete or partial response to the most recent chemotherapy
The study was designed to measure how long women lived with epithelial ovarian, fallopian tube, or primary peritoneal cancer without their disease getting worse. The treatment benefit of ZEJULA was independently studied in women with an inherited BRCA mutation and without an inherited BRCA mutation.1
Get more information about what ovarian cancer recurrence might mean for youUnderstand Recurrent Ovarian Cancer
Learn how ZEJULA may extend your time in responseSEE CLINICAL TRIAL RESULTS
Find resources and information that may help you access ZEJULAGet Access and Support
*BRCA stands for breast cancer susceptibility gene. BRCA refers to particular genes that produce proteins that suppress tumors. BRCA proteins help repair damaged DNA in cells. You may hear the terms BRCA1 and BRCA2 proteins. Mutations in BRCA may mean that it no longer functions. A BRCA gene mutation can be inherited from a parent. When this happens, it is known as a germline BRCA (gBRCA) mutation. When there is a mutation in BRCA that is not passed from a parent to a child, it is called a somatic BRCA (sBRCA) mutation.
†This means a change (also called a mutation) has been noted in the BRCA gene. A positive result does not mean that cancer will occur, but this puts you at a higher risk for certain cancers.
‡65 women who were BRCA-positive received a placebo (eg, sugar pill), and 116 women who were BRCA-negative received a placebo.