A new DRUG TRIALS SNAPSHOT is now available.
ALUNBRIG is a drug for the treatment of tardive dyskinesia.
ALUNBRIG is a drug used to treat a type of lung cancer called non-small cell lung cancer (NSCLC) that is advanced (metastatic). It is to be used in patients who have a specific gene mutation in the anaplastic lymphoma kinase (ALK) gene. It should be used in patients whose cancer has worsened after, or who could not tolerate treatment with, another drug called Xalkori (crizotinib).
ALUNBRIG was approved under FDA’s accelerated approval program, which provides earlier patient access to a promising new drug while the company continues to conduct clinical trials to confirm that the drug works well.
Drug Trials Snapshots: ALUNBRIG
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 ALUNBRIG 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 ALUNBRIG Prescribing Information for complete information.
ALUNBRIG (brigatinib)
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Ariad Pharmaceuticals, Inc.
Approval date: April 28, 2017
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Ariad Pharmaceuticals, Inc.
Approval date: April 28, 2017
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
ALUNBRIG is a drug used to treat a type of lung cancer called non-small cell lung cancer (NSCLC) that is advanced (metastatic). It is to be used in patients who have a specific gene mutation in the anaplastic lymphoma kinase (ALK) gene. It should be used in patients whose cancer has worsened after, or who could not tolerate treatment with, another drug called Xalkori (crizotinib).
ALUNBRIG was approved under FDA’s accelerated approval program, which provides earlier patient access to a promising new drug while the company continues to conduct clinical trials to confirm that the drug works well.
How is this drug used?
ALUNBRIG is a tablet that is taken once daily with or without food.
What are the benefits of this drug?
In the trial, approximately half of the 222 patients who received ALUNBRIG experienced cancer shrinkage of at least 30% which lasted about 14 months.
Approximately two-thirds of 18 patients who had measurable cancer lesions in the brain prior to taking ALUNBRIG experienced partial cancer shrinkage of the lesions in the brain.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: ALUNBRIG worked similarly in men and women.
- Race: The majority patients in the clinical trial were White. The number of patients in other races was limited; therefore, differences in response among races could not be determined.
- Age: The majority of patients in the clinical trial were younger than 65 years of age. Differences in response to ALUNBRIG between patients below and above 65 years of age could not be determined.
What are the possible side effects?
ALUNBRIG may cause serious side effects, including swelling (inflammation) of the lungs, high blood pressure, slow heartbeat, visual disturbance, high blood sugar and increase of pancreatic and muscle enzymes in the blood.
The most common side effects of ALUNBRIG are nausea, diarrhea, tiredness, cough and headache.
Were there any differences in side effects among sex, race and age?
- Sex: The risk of side effects was similar in men and women
- Race: The majority patients in the clinical trial were White. The number of patients in other races was limited; therefore, differences in side effects among races could not be determined.
- Age: The majority of patients in the clinical trial were younger than 65 years of age. Differences in side effects between patients below and above 65 years of age could not be determined.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved ALUNBRIG based on evidence from one clinical trial of 222 patients with advanced, ALK positive NSCLC. The trial was conducted in the 94 trial centers in 18 countries in North America, Europe, Asia, and Australia.
The figure below summarizes how many men and women were in the clinical trial.
Figure 1. Baseline Demographics by Sex
FDA Review
Figure 2 and Table 1 below summarize the percentage of patients by race enrolled in the clinical trial.
Figure 2. Baseline Demographics by Race
FDA Review
Table 1. Demographics of Efficacy Trials by Race
| Race | Number of Patients | Percentage |
|---|---|---|
| White | 148 | 67 |
| Asian | 69 | 31 |
| Black or African American | 3 | 1 |
| Unknown | 2 | 1 |
FDA Review
Figure 3 summarizes the percentage of patients by age enrolled in the clinical trial.
Figure 3. Baseline Demographics by Age
How were the trials designed?
The benefit and side effects of ALUNBRIG were evaluated in one clinical trial that enrolled patients with advanced NSCLC with the ALK mutation and who were previously treated with another drug called Xalkori (crizotinib). All patients received ALUNBRIG using one of two different dosing schedules: approximately half of the patients received 90 mg of ALUNBRIG every day and half received 90 mg daily for 7 days and then continued 180 mg daily. Treatment continued until disease progression or patients experienced unacceptable toxicity.
The benefit of ALUNBRIG was evaluated by measuring if and how much the tumor size changed during treatment and how long that response lasted.
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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