The Food and Drug Administration (FDA) approves prescription drugs such as Brukinsa to treat certain conditions. Specifically, Brukinsa is approved to treat a type of blood cancer called mantle cell lymphoma (MCL).
Brukinsa may also be used off-label for other conditions. With off-label use, a drug that’s approved to treat one condition is used to treat a different condition.
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For information on the off-label use of Brukinsa for chronic lymphocytic leukemia (CLL), see the section “Brukinsa for CLL” just above. And for information on other off-label uses of the drug, see the section “Brukinsa for other conditions” below.
Brukinsa for mantle cell lymphoma (MCL)
Brukinsa is FDA-approved to treat MCL. It’s approved for this use in adults who’ve used at least one other past treatment for the condition.
MCL is a form of cancer that affects certain white blood cells called B cells. With MCL, your B cells grow abnormally. The condition can also cause enlarged lymph nodes in certain areas of your body.
The abnormal B-cells caused by MCL can crowd out your healthy blood cells, which normally help your body fight off infections. This means that with MCL, you may be more prone to getting infections than are people who don’t have MCL.
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Brukinsa works by inhibiting (blocking) the action of a protein called Bruton’s tyrosine kinase (BTK). This protein helps to signal B cells to grow and multiply. (Cells that multiply are making more cells.)
By stopping the abnormal B cells from multiplying, Brukinsa can reduce tumor growth in some people.
It’s important to note that Brukinsa received accelerated approval from the FDA to treat MCL. Accelerated approval is based on information from early clinical trials of the drug. The FDA’s decision for full approval of Brukinsa will be made after additional clinical trials have been completed.
Effectiveness for mantle cell lymphoma
Brukinsa was studied in two different clinical trials of adults with MCL. Everyone who participated in the trials had received at least one other past treatment for their MCL. And all of the people in the studies took Brukinsa. There weren’t any people in the studies who took a different drug or a placebo (treatment with no active drug).
The first study showed that:
- 59% of people who took Brukinsa had a complete response to treatment. (With a complete response, their cancer completely went away with treatment.)
- 24% of people had a partial response to treatment. (With a partial response, their cancer partially went away with treatment.)
- Half of the people in the study kept these responses for at least 19.5 months.
In the second study, the following results were seen:
- 22% of people taking Brukinsa had a complete response to treatment.
- 62% of people taking Brukinsa had a partial response.
- Half of the people in the study kept these responses for at least 18.5 months.
Brukinsa for other conditions
In addition to the use described above, Brukinsa may be used off-label for other purposes. Off-label drug use is when a drug that’s approved for one use is used for a different one that’s not approved. And you may wonder if Brukinsa is used for certain other conditions. Below is information on other possible uses for Brukinsa.
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For information on using Brukinsa off-label to treat chronic lymphocytic leukemia (CLL), see the section “Brukinsa for CLL” above.
Brukinsa for other forms of lymphoma (off-label use)
There are several ongoing trials testing Brukinsa as a treatment for different types of lymphomas than it’s approved to treat. (Lymphomas are types of cancers that affect certain blood cells.)
For example, Brukinsa is currently being studied as a treatment for CLL. And sometimes the drug is used off-label for this condition. For more information about using Brukinsa to treat CLL, see the section “Brukinsa for CLL” above.
In addition, Brukinsa is being studied as a treatment option for the following forms of lymphoma:
- marginal zone lymphoma (MZL)
- small lymphocytic lymphoma (SLL)
- Waldenström’s macroglobulinemia (WMG)
You can view a full list of current clinical trials of Brukinsa at ClinicalTrials.gov. And some of the trials listed on this website are recruiting people to join them.
If you have questions about using Brukinsa to treat certain forms of lymphoma, talk with your doctor. Also talk with your doctor if you’d like more information about participating in ongoing trials.
Brukinsa and children
Brukinsa hasn’t been studied in children. So it’s not known whether the drug is safe or effective for use in people younger than 18 years of age.
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