A new DRUG TRIALS SNAPSHOT is now available
See more Drug Trials Snapshots or contact us with questions at Snapshots@fda.hhs.gov.
Drug Trials Snapshots: VIZIMPRO
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 VIZIMPRO 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 VIZIMPRO Prescribing Information for complete information.
VIZIMPRO (dacomitinib)
vih-ZIM-pro
Pfizer
Approval date: September 27, 2018
vih-ZIM-pro
Pfizer
Approval date: September 27, 2018
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
VIZIMPRO is a drug used to treat patients with a type of lung cancer called advanced non-small cell lung cancer (NSCLC). It is to be used as a first treatment in patients whose cancer has spread to other parts of the body (metastatic) and has certain types of gene mutation.
How is this drug used?
VIZIMPRO is a tablet taken by mouth once a day.
What are the benefits of this drug?
Patients who were treated with VIZIMPRO lived about 15 months without disease progression in comparison to patients who receved comparator drug gefitinib who lived about 9 months without disease progression.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: VIZIMPRO worked similarly in men and women.
- Race: The majority of patients were Asians. Therefore, differences in how well the drug work among races could not be determined.
- Age: VIZIMPRO worked similarly in patients below and above 65 years of age.
What are the possible side effects?
VIZIMPRO may cause serious side effects including inflammation of the lungs, severe diarrhea, and skin reactions.
The most common side effects of VIZIMPRO are diarrhea, rash, nail infection, mouth sores, decreased appetite, dry skin, decreased weight, hair loss, caugh and skin itching.
Were there any differences in side effects among sex, race and age?
- Sex: The occurrence of side effects was similar in men and women.
- Race: The majority patients in the clinical trial were Asians. Differences in occurrence of side effects among races could not be determined.
- Age: The occurrence of side effect was similar in patients below and above 65 years of age.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved VIZIMPRO based on evidence from one clinical trial (NCT01774721) with a total of 452 patients with advanced non-small cell lung cancer. Trial was conducted in Asia.
Figure 1 summarizes how many men and women were enrolled in the clinical trial.
Figure 1. Baseline Demographics by Sex
FDA Review
Figure 2 and Table 1 summarize the percentage of patients by race enrolled in the clinical trial.
Figure 2. Baseline Demographics by Race
FDA Review
Table 1. Baseline Demographics by Race
Race
|
Number of Patients
|
Percentage
|
|---|---|---|
White
|
105
|
23
|
Black or African American
|
1
|
less than 1
|
Asian
|
346
|
77
|
FDA Review
The figure below summarizes how many patients by age group were enrolled in the clinical trial.
Figure 3. Baseline Demographics by Age
FDA Review
How were the trials designed?
The benefits and side effects of VIZIMPRO were evaluated in one clinical trial.
Enrolled patients had a type of non-small cell lung cancer (NSCLC) that contains specific epidermal growth factor receptor mutations. Patients either never received any chemotherapy treatment for their cancer or the cancer came back after completion of previous chemotherapy treatment.
Patients were treated with either VIZIMPRO or gefitinib (an approved drug for treatment of NSCLC) until either disease progresion or developmet of intolerable side effects.
The benefit of VIZIMPRO in comparison to gefitinimib was assessed by the length of time that patients lived without disease progression (progression free survival or PFS).
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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