Drug Trials Snapshots: LUMOXITI
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 LUMOXITI 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 LUMOXITI Prescribing Information for complete information.
LUMOXITI (moxetumomab pasudotox-tdfk)
loo‐MOCKS‐eh‐tee
AstraZeneca
Approval date: September 13, 2018
loo‐MOCKS‐eh‐tee
AstraZeneca
Approval date: September 13, 2018
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
LUMOXITI is used to treat adults with hairy cell leukemia (HCL) whose disease has come back or has not improved after at least two prior treatments.
Hairy cell leukemia is a rare, slow-growing cancer of the blood. The disease is called hairy cell leukemia because the leukemia cells look "hairy" when viewed under a microscope.
How is this drug used?
LUMOXITI is given by a healthcare provider directly into the bloodstream through a needle in the vein. This is known as an intravenous, or IV infusion. It takes about 30 minutes to receive an LUMOXITI infusion.
LUMOXITI is given on Days 1, 3, and 5 of each 28-day treatment cycle.
What are the benefits of this drug?
In the clinical trial, thirty percent (24 of 80) of patients with HCL achieved success (durable complete response). This means that blood counts that returned to normal values were maintained for more than 6 months.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: LUMOXITI worked similarly in men and women.
- Race: Most of the patients were White. Differences in how well the drug worked among races could not be determined because of the small number of patients in other races.
- Age: LUMOXITI worked better in patients younger than 65 years of age.
What are the possible side effects?
LUMOXITI may cause serious side effects including life threatening conditions called capillary leak syndrome and hemolytic uremic syndrome. Other serious side effects are kidney damage, infusion-related reactions and electrolyte abnormalities.
The most common side effects of LUMOXITI are infusion related reactions, body swelling, nausea, fatigue, headache, fever, constipation, anemia, and diarrhea.
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: Most of the patients were White. Differences in the occurrence of side effects among races could not be determined because of the small number of patients in other races.
- Age: The occurrence of kidney side effects was higher in patients older than 65 years of age.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved LUMOXITI based on evidence from one clinical trial (NCT 01829711) that was conducted in the United States, and Europe. Patients who participated in the trial had hairy cell leukemia and have received at least two prior treatments for their disease.
Figure 1 summarizes how many men and women were in the trial.
Figure 1. Baseline Demographics by Sex
FDA review
Figure 2 and Table 1 below summarize by race patients who participated in the trial.
Figure 2. Baseline Demographics by Race
FDA review
Table 1. Baseline Demographics by Race
| Race | Number of Patients | Percentage |
|---|---|---|
| White | 72 | 90 |
| Black or African American | 1 | 1 |
| Asian | 1 | 1 |
| Other | 3 | 4 |
| Missing | 3 | 4 |
FDA review
Figure 3 summarizes by age group patients who participated in the trial.
Figure 3. Baseline Demographics by Age
FDA review
How were the trials designed?
There was one trial that evaluated the benefit and side effects of LUMOXITI in patients with hairy cell leukemia whose disease has come back or has not improved after two previous treatments.
Patients received LUMOXITI infusion on Days 1, 8, and 15 of a 28-day treatment cycle. Treatment continued for a maximum of 6 cycles or until disease progression or unacceptable side effects.
The benefit of LUMOXITI was evaluated by measuring how many patients achieved success called durable complete response. That meant that after the therapy was completed blood cell counts increased to normal values and remained at that level for 6 months without any transfusions or additional medicines for at least 4 weeks.
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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