A new DRUG TRIALS SNAPSHOT is now available.
Drug Trial Snapshot: BRAFTOVI
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 BRAFTOVI 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 BRAFTOVI Prescribing Information for complete information.
BRAFTOVI (encorafenib)
(braf-TOE-vee)
Array Biopharma
Approval date: June 27, 2018
(braf-TOE-vee)
Array Biopharma
Approval date: June 27, 2018
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
BRAFTOVI is a drug which is to be used with another drug, binimetinib, to treat a type of skin cancer called melanoma. BRAFTOVI is only to be used in patients who have melanoma with a specific abnormal gene (called a BRAF V600E or V600K mutation) that has spread to other parts of the body (advanced melanoma) or cannot be removed by surgery.
How is this drug used?
BRAFTOVI is a tablet. A total of 450 mg is taken by mouth once daily with binimetinib.
What are the benefits of this drug?
BRAFTOVI plus binimetinib delays disease worsening. In addition, 63% of patients taking BRAFTOVI plus binimetinib experienced complete or partial shrinkage of their tumors.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: BRAFTOVI worked similarly in men and women.
- Race: The majority of patients were White. The number of patients in other races was limited; therefore, differences in how well the drug worked among races could not be determined.
- Age: BRAFTOVI worked similarly in patients younger and older than 65 years of age.
What are the possible side effects?
BRAFTOVI in combination with binimetinib may cause serious side effects including new skin cancers, bleeding, eye inflammation (uveitis) and heart rhythm problems (due to QT prolongation).
The most common side effects of treatment with BRAFTOVI when given with binimetinib are fatigue, nausea, vomiting, abdominal pain and joint pain.
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 of patients were White. The number of patients in other races was limited; therefore, differences in side effects among races could not be determined.
- Age: The occurrence of side effects was similar in patients younger and older than 65 years of age.
WHO WAS IN THE STUDIES?
Who participated in the clinical trials?
The FDA approved BRAFTOVI based primarily on evidence from one clinical trial (NCT01909453) of 383 patients with BRAF V600 mutation-positive melanoma that was advanced or could not be removed by surgery. The trial was conducted at 162 sites in Europe, North America and various countries around the world.
Figure 1 summarizes how many men and women were in the clinical trial.
Figure 1. Baseline Demographics by Sex
Clinical Trial Data
Figure 2 and Table 1 summarize the percentage of patients by race in the clinical trial.
Figure 2. Baseline Demographics by Race
Clinical Trial Data
Table 1. Baseline Demographics by Race
Race
|
Number of Patients
|
Percentage
|
|---|---|---|
White
|
348
|
91
|
Asian
|
13
|
3
|
American Indian or Alaska Native
|
2
|
0.5
|
Other
|
5
|
1
|
Unknown
|
13
|
3
|
Missing data
|
2
|
0.5
|
The figure below summarizes the percentage of patients by age in the clinical trial.
Figure 3. Baseline Demographics by Age 
Clinical Trial Data
How were the trials designed?
The benefits and side effects of BRAFTOVI were evaluated in one clinical trial. Enrolled patients had a melanoma with a certain type of abnormal gene (called BRAF V600E or V600K mutation) that had spread to other parts of the body or that could not be removed by surgery.
All patients received daily either BRAFTOVI together with binimetinib or vemurafenib (FDA approved drug to treat melanoma). Both, patients and investigators knew which treatment had been given. Treatment continued until disease progression or development of unacceptable side effects.
The benefit of BRAFTOVI was assessed by measuring the length of time it took the disease to worsen in patients who received BRAFTOVI given with binimetinib and comparing it to the time the disease took to worsen in patients treated with vemurafenib.
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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