CALQUENCE and Mantle Cell Lymphoma (MCL)

CALQUENCE is a type of medicine called a Bruton tyrosine kinase inhibitor, or BTKi. BTK inhibition has been shown to help treat MCL.

About Mantle Cell Lymphoma (MCL)

Lymphtissue

Lymph tissue is found throughout the body and is part of a system that helps the body fight infection and disease.

 

Cancer of the lymph system is called lymphoma and it can begin and travel almost anywhere in the body.

 

The body has two main types of lymphocytes or white blood cells that can develop into lymphomas:

B-cell B-cell

B cells

B lymphocytes

&
t-cell t-cell

T cells

T lymphocytes

 

There are two main forms of lymphoma:

Hodgkin lymphoma and non-Hodgkin lymphoma.

Mantle cell lymphoma, or MCL, is a rare type of B-cell non-Hodgkin lymphoma.

man

Mantle cell lymphoma affects mostly men over the age of 60.

bulb

The disease is called “mantle cell lymphoma” because the tumor cells originally come from the “mantle zone” of lymph nodes.

treatment

Relapsed MCL Patients with MCL may respond well to treatment once the disease is diagnosed but within a few years the disease may return after treatment. This means patients have relapsed MCL.

Refractory MCL Patients may also have refractory MCL. Refractory MCL means that the disease does not respond to treatment.

What is CALQUENCE® (acalabrutinib)?CALQUENCE® (acalabrutinib)?

CALQUENCE is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer. It is not known if CALQUENCE is safe and effective in children.

CALQUENCE is a type of medicine called a Bruton tyrosine kinase inhibitor, or BTKi.

BTK inhibition has been shown to help treat MCL.

The effect of CALQUENCE was measured by how many patients responded to treatment and how long the response lasted.

In a clinical study* of patients taking CALQUENCE,

80%

 

80% responded to CALQUENCE, meaning radiographic and other tests showed that their cancer reduced in size and did not spread.

*In this clinical study, 124 people with MCL who had already had at least one prior therapy received 100 mg of CALQUENCE twice daily.

How does CALQUENCE work?

CALQUENCE targets and helps block a protein, called BTK, that contributes to cancer cell growth and survival. It is a type of medicine called a Bruton tyrosine kinase inhibitor, or BTKi.

BTK inhibition has been shown to help treat patients with MCL.

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IMPORTANT SAFETY INFORMATION

CALQUENCE may cause serious side effects, including:

  • Bleeding problems (hemorrhage) may happen during treatment with CALQUENCE, and can be serious. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding, including:
    • blood in your stools or black stools (looks like tar)
    • pink or brown urine
    • unexpected bleeding, or bleeding that is severe or you cannot control
    • vomit blood or vomit that looks like coffee grounds
    • cough up blood or blood clots
    • dizziness
    • weakness
    • confusion
    • change in your speech
    • headache that lasts a long time
  • Infections. Infections can happen during treatment with CALQUENCE. These infections can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, or flu-like symptoms.
  • Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with CALQUENCE, but can also be severe. Your healthcare provider should do monthly blood tests to check your blood counts.
  • Second primary cancers. New cancers have happened in people during treatment with CALQUENCE, including cancers of the skin. Use sun protection when you are outside in sunlight.
  • Heart rhythm problems (atrial fibrillation and atrial flutter) have happened in people treated with CALQUENCE. Tell your healthcare provider if you have any of the following signs or symptoms:
    • your heartbeat is fast or irregular
    • feel lightheaded or dizzy
    • pass out (faint)
    • shortness of breath
    • chest discomfort

The most common side effects of CALQUENCE include:

  • headache
  • diarrhea
  • tiredness
  • muscle aches
  • bruising

These are not all the possible side effects of CALQUENCE. Call your doctor for medical advice about side effects.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What is CALQUENCE?

CALQUENCE is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer.

It is not known if CALQUENCE is safe and effective in children.

Please see complete Prescribing Information including Patient Information.