October 1, 2015
A new Snapshot for VARUBI is available on the Drug Trials Snapshots website.
You can find the new Snapshot at VARUBI SNAPSHOT. VARUBI is a drug used to prevent a delayed form of nausea and vomiting that can occur more than 24 hours after cancer treatment. (Chemotherapy).
Drug Trials Snapshots provide information about who participated in clinical trials that supported the FDA approval of new drugs. The information provided in these Snapshots also highlights whether there were any differences in the benefits and side effects among sex, race and age groups.
See more Drug Trial Snapshots or contact us with questions at Snapshots@fda.hhs.gov.
Drug Trials Snapshots: VARUBI
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the VARUBI Prescribing Information for complete information.
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the VARUBI Prescribing Information for complete information.
VARUBI (rolapitant)
(vuh ROO bee)
Tesaro Inc.
Approval date: September 1, 2015
(vuh ROO bee)
Tesaro Inc.
Approval date: September 1, 2015
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
VARUBI is a drug used to prevent a delayed form of nausea and vomiting that can occur more than 24 hours after cancer treatment (chemotherapy).
How is this drug used?
VARUBI is a tablet that is taken one to two hours before chemotherapy. It is taken along with other medicines used to prevent nausea and vomiting.
VARUBI should be taken on the first day of each cycle of chemotherapy and not more than one time every 14 days.
What are the benefits of this drug?
Patients taking VARUBI experienced less vomiting and less need for additional medication to treat nausea or vomiting than patients receiving a “sugar pill” (placebo).
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
Subgroup analyses were conducted for sex, race, and age.
- Sex: VARUBI worked similarly in men and women.
- Race: VARUBI worked similarly in all races studied.
- Age: VARUBI worked similarly in patients younger than 65 years and patients 65 years and older.
What are the possible side effects?
The most common side effects are low white cell blood count, poor appetite, hiccups, and dizziness.
Were there any differences in side effects among sex, race and age?
- Sex: VARUBI had a similar side effect profile in men and women.
- Race: The number of patients in the non-white subgroups was limited. Therefore, differences in side effects among races could not be concluded.
- Age: VARUBI had a similar side effect profile in patients below 65 years of age and those 65 years and above.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved VARUBI based on evidence from 3 clinical trials of 2595 cancer patients who were receiving chemotherapies known to cause nausea and vomiting. The trials were conducted in Europe, North, Central and South America, Asia and South Africa.
The figure below summarizes how many men and women were in the clinical trials.
Figure 1. Baseline Demographics by Sex
Source: Company Trial Data
The figure and table below summarize the percentage of patients by race in the clinical trials.
Figure 2. Baseline Demographics by Race
<1%=less than 1%
Source: Company Trial Data
Source: Company Trial Data
Table 1. Baseline Demographics by Race
| Race | Number of Patients | Percentage of Patients |
|---|---|---|
| White | 1934 | 75% |
| Asian | 371 | 14% |
| Black or African American | 64 | 2% |
| American Indian or Alaska Native | 29 | 1% |
| Native Hawaiian or Other Pacific Islander | 3 | less than 1% |
| Other | 194 | 8% |
Source: Company Trial Data
The figure below sumarizes the percentage of patients by age in the clinical trials.
Figure 3. Baseline Demographics by Age
Source: Company Trial Data
How were the trials designed?
There were three trials that evaluated the benefits and side effects of. In two trials patients were receiving chemotherapy which is known to cause nausea and vomiting often, and in one trial they were receiving chemotherapy which causes nausea and vomiting less often. Patients in all three trials were randomly assigned to receive either or placebo drug in addition to their regular medications for nausea and vomiting. Neither the patients nor the health care providers knew which treatment was being given until after the trial was complete.
The trials counted the number of patients who had no vomiting and used no medications for nausea or vomiting from 25 to 120 hours after the first day of the first cycle of chemotherapy, and compared VARUBI and placebo group.
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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