A new DRUG TRIALS SNAPSHOT is now available.
ZEJULA is a drug used for the maintenance treatment of adult patients with recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. It is to be used in patients who have responded to their most recent platinum-based chemotherapy regimen with either complete or partial tumor shrinkage.
See more Drug Trial Snapshots or contact us with questions at Snapshots@fda.hhs.gov.
ZEJULA (niraparib)
zuh-JOO-luh
Tesaro, Inc.
Approval date: March 27, 2017
zuh-JOO-luh
Tesaro, Inc.
Approval date: March 27, 2017
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
ZEJULA is a drug used for the maintenance treatment of adult patients with recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. It is to be used in patients who have responded to their most recent platinum-based chemotherapy regimen with either complete or partial tumor shrinkage.
How is this drug used?
Three capsules (total of 300 mg) are taken once a day with or without food.
What are the benefits of this drug?
In the trial, women taking ZEJULA experienced a longer time period before their tumors worsened, in comparison to women who took placebo. Information on overall survival of these women is not available at this time.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
All the patients in the trial were women, therefore only race and age differences were analyzed.
- Race: The majority of patients in the clinical trials were White. Differences in response to ZEJULA among races could not be determined.
- Age: ZEJULA worked similarly in patients above and below 65 years of age.
What are the possible side effects?
ZEJULA may cause serious side effects including a bone marrow disorder (myelodysplastic syndrome), leukemia, and life-threatening high blood pressure.
Some of the most common side effects of ZEJULA are low blood cell counts (red, white and platelets), nausea, tiredness, constipation, vomiting, and stomach-area pain.
Were there any differences in side effects among sex, race and age?
All the patients in the trial were women, therefore only race and age differences were analyzed.
- Race: The majority patients in the clinical trials were White. Differences in side effects among races could not be determined.
- Age: The occurrence of side effect was similar between patients below and above 65 years of age.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The benefit and side effects of ZEJULA were evaluated based on evidence from 553 women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The trial was conducted in the USA, Canada, Europe, and Israel.
Figure 1 summarizes how many women were in the clinical trial.
Figure 1. Baseline Demographics by Sex
Adapted from FDA review
Figure 2 and Table 1 below summarize the percentage of patients by race in the clinical trial.
Figure 2. Baseline Demographics by Race
Adapted from FDA review
Table 1. Baseline Demographics by Race
| Race | Number of Patients | Percentage |
|---|---|---|
| White | 480 | 87 |
| Asian | 19 | 3 |
| Black or African American | 7 | 1 |
| American Indian or Alaska Native | 1 | less than 1 |
| Unknown | 46 | 9 |
Adapted from FDA review
Figure 3 below summarizes the percentage of patients by age in the clinical trial.
Figure 3. Baseline Demographics by Age
Adapted from FDA review
How were the trials designed?
The benefit and side effects of ZEJULA were evaluated in one clinical trial of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. All patients had received at least two prior platinum regimens and had responded most recently (within 8 months) to a platinum-based therapy with either complete or partial tumor shrinkage.
Patients were tested with an FDA-approved test to determine whether they had a specific gene mutation, called a deleterious or germline BRCA mutation and then received either ZEJULA or placebo capsules once a day. Neither the patients nor the health care providers knew which treatment was being given until the trials were completed. The treatment continued until the disease progressed or the side effects became too toxic.
The benefit of ZEJULA was evaluated by measuring the duration of time in each group before the tumors worsened.
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
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