Zejula (niraparib) is a targeted therapy for certain types of advanced ovarian cancer. Unlike chemotherapy, targeted therapies aim at specific proteins in cancer cells that help them to grow. This limits the harm done to healthy cells. The FDA first approved Zejula in 2017 for continued treatment of certain ovarian cancers that returned after improving with platinum-based chemotherapy. In 2020, the approval was expanded to also include maintenance therapy for first-time advanced ovarian cancers that improved with platinum-based chemotherapy.
How Does Zejula Work in Advanced Ovarian Cancer?
In platinum-based chemotherapy, the platinum in the medicine binds to the genetic material (DNA) of cancer cells. This damages the cancer cells and eventually kills them. But the cancer is likely to return in many people partly because a protein called PARP attaches to the damaged DNA and helps it repair.
Zejula may delay the return of cancer by stopping PARP and preventing the repair of the damaged DNA.
Is It Right for Me?
Zejula may be the right choice for you if:
- You have advanced ovarian cancer. This includes cancer of the ovaries, fallopian tubes (ducts that connect the ovaries to the uterus), or peritoneum (the lining that covers the organs inside your abdomen).
- Your cancer has improved completely or partially with platinum-based chemotherapy.
- Your cancer has returned after successful treatment with platinum-based chemotherapy, and you have certain changes in a set of genes called BRCA, confirmed by specific tests.
Your doctor will test you for gene changes and review your medical history to decide if Zejula is right for you.
How Was Zejula Studied for Treating Advanced Ovarian Cancer?
Two clinical studies, the NOVA trial and the PRIMA trial, were done to look at the benefits and risks of Zejula in people with advanced ovarian cancer.
The main question both studies wanted to answer was: How well does Zejula work in people with advanced ovarian cancer?
To learn this, the researchers measured how long it took for the people who took Zejula to experience worsening of cancer compared with those who didn’t take the medicine. This is called ‘progression-free survival’ and shows how well a medicine controls a disease.
What medicines did the people in the studies take?
People in both studies were randomly selected to take either Zejula or placebo. The placebo looked like Zejula but didn’t contain any medicine. Neither the people in the study nor the doctors knew who received Zejula or placebo.
The PRIMA trial included people with first-time advanced ovarian cancers that had improved with platinum-based chemotherapy.
To take part in the study, people had to:
- Be women at least 18 years old
- Have stage III or IV ovarian cancer that could not be further operated on
- Have received platinum-based chemotherapy after surgery
- Show complete or partial improvement in their cancer after chemotherapy
Who was excluded from the study?
People could not be in this study if they:
- Had certain types of ovarian cancer
- Had advanced ovarian cancer but did not have any signs of cancer after surgery
- Had more than two surgeries for ovarian cancer
- Had taken medicines similar to Zejula
- Were taking certain other medicines for ovarian cancer
- Had certain blood conditions because of previous chemotherapy
- Were pregnant or breastfeeding or expected to become pregnant
What was the study population?
- A total of 733 people were in this study.
- About 80% of the people in the study had cancer of the ovary, about 13% had cancer of the fallopian tube, and less than 10% had cancer of the peritoneum.
- About 89% were White, 2% were Black, 3% were Asian, 1% were American Indian or Alaska Native, 1% were Native Hawaiian or Other Pacific Islander, and 5% were from other racial backgrounds.
- The age of the people in the study ranged from 32 to 88. A total of 39% were 65 or older and 10% were 75 or older.
A total of 487 people took Zejula, and 246 people took placebo.
How long was the study?
People continued to take Zejula or placebo until their cancer got worse or they had unacceptable side effects. They were followed up for about 3.5 years.
About 21% of people who took Zejula and 16% of those who took placebo were in the study for longer than 3 years.
What was the main benefit?
People who took Zejula had significantly longer progression-free survival before their cancer worsened compared to those who took placebo.
The NOVA trial was done in people with ovarian cancers that returned after improving with platinum-based chemotherapy.
The study included 553 women who were at least 18 years old and had certain types of advanced ovarian cancers:
- All had seen their cancer improve after receiving platinum-based chemotherapy.
- The age of the people in the study ranged between 33 and 84. A total of 35% were 65 or older and 8% were 75 or older.
The study excluded people who had certain other types of cancers and conditions, or those who were pregnant or breastfeeding.
A total of 372 people took Zejula and 181 people took placebo. In addition, the people in the study were divided into two groups: those who had inherited changes in their BRCA genes (203 people) and those who had not (350 people).
In both groups, especially in those with changes in BRCA genes, people who took Zejula lived significantly longer before their cancer worsened compared to those who took placebo.
What Are the Serious Side Effects?
In addition to common side effects, Zejula may rarely cause:
- A serious bone marrow problem called myelodysplastic syndrome
- A type of blood cancer called acute myeloid leukemia
Although a low count of blood cells (red blood cells, white blood cells, and platelets) is a common side effect of Zejula, it can also be a sign of serious bone marrow or blood problems. Inform your doctor if you feel weak or tired, are losing weight, get frequent infections, have a fever, are short of breath, see blood in your urine or stool, or bruise or bleed more easily. Your doctor will also regularly check your blood cell counts.
A rise in blood pressure is a common side effect of Zejula, but it can sometimes become serious. Your doctor will regularly check your blood pressure and heart rate.
- A type of brain nerve problem called posterior reversible encephalopathy syndrome
This involves a swelling of the brain. The symptoms can appear within a few hours and, if caught quickly, can be treated. Inform your doctor immediately if you have headache, vision changes, confusion, or seizure, with or without high blood pressure.
How Will Treatment Be Monitored?
Your health care provider will regularly check how well Zejula is working for your cancer through looking at results of tests such as blood tests and CT scans, MRI scans, and bone scans. Take it exactly as your health care provider tells you. Do not change your dose or stop taking Zejula unless your health care provider tells you to.
How Do Other Medicines, Foods, or Environmental Factors Interact With Zejula?
No studies have been done in humans to learn if other medicines or foods can interfere with how Zejula works in your body or if Zejula affects other medicines. However, lab experiments have shown that Zejula can stop a protein that is necessary to break down some medicines before they leave the body. This means that Zejula may be able to cause these medicines to stay in the body longer than they should. Metformin (a medicine that people take to treat diabetes) is an example of such medicines. No formal studies have been completed to confirm this.
Inform your health care provider and pharmacist about all the other prescription and over-the-counter medicines, vitamins, supplements, and herbal products you take, so they can monitor any changes and adjust the dosage of your medicines if needed.
Some people have shown sensitivity to sunlight (sunburn-like skin reactions) while taking Zejula. Wear protective clothing and sunscreen when outdoors.
How Can I Get Zejula?
You will need a prescription from a health care provider who has experience in the use of medicines for cancer (an oncologist). Your oncologist will either directly dispense Zejula to you or arrange for you to get it at a specialty pharmacy.
If you need support paying for Zejula, check out www.togetherwithgskoncology.com to learn more about the reimbursement support program or to ask about insurance coverage, copay, or assistance with out-of-pocket expenses. You can also contact the manufacturer at 844-447-5662.
