BRUKINSA is a BTK inhibitor that
was designed to completely block BTK

Why is a BTK inhibitor important for
Waldenström’s macroglobulinemia (WM) treatment?

WM is caused by rapid growth and spread of cancerous B cells.

  • Bruton’s tyrosine kinase (BTK) is a protein that signals to cancerous B cells, helping them to grow and spread
  • Blocking BTK can help stop this signaling

The significance of completely blocking BTK on treatment responses has not been established.

Treatment that is complete and consistent.

How well does BRUKINSA work?

BRUKINSA’s effectiveness was assessed in the ASPEN study. The aim of that study was to compare BRUKINSA with ibrutinib, another FDA-approved BTK inhibitor, to see if BRUKINSA had better treatment responses for people with Waldenström’s macroglobulinemia. This type of study is sometimes called a “head-to-head” trial.

The trial included 201 people who were either newly diagnosed with, or who had received at least one prior treatment for, WM.

Although BRUKINSA did not meet the requirement to show that it was better than ibrutinib, as both BRUKINSA and ibrutinib had a 78% combined response rate (CR + VGPR + PR), BRUKINSA did show a higher VGPR: 16% for BRUKINSA and 7% for ibrutinib. In addition, 94% of patients on BRUKINSA continued to respond for a year or longer and 88% of patients on ibrutinib continued to respond for a year or longer.

Neither treatment had a complete response in this study.




The study included people who had been previously treated for their cancer and those who had not, as well as people with and without certain mutations (MYD88MUT, MYD88WT, CXCR4WT, and CXCR4WHIM). In the exploratory analysis of 26 MYD88WT patients who received BRUKINSA, 50% had either a VGPR or PR and 27% had a VGPR.

Results were consistent across each of these groups.

It is important to know that a response, even a VGPR, does not mean the cancer has been cured.

For definitions of treatment response, please see the table at the bottom of the page.

The effectiveness of BRUKINSA may vary for different people.

What are the possible side effects of BRUKINSA?

BRUKINSA may cause serious side effects, including:


Bleeding problems (hemorrhage) that can be serious and may lead to death. 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
  • increased bruising
  • dizziness
  • weakness
  • confusion
  • change in speech
  • headache that lasts a long time

Infections that can be seriousand may lead to death. Tell your healthcare provider right awayif 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 BRUKINSA, but can also be severe. Your healthcare provider should do blood tests during treatment with BRUKINSA to check your blood counts.

Second primary cancers. New cancers have happened in people during treatment with BRUKINSA, including cancers of the skin or other organs. Your healthcare provider will check you for other cancers during treatment with BRUKINSA. Use sun protection when you are outside in sunlight.

Heart rhythm problems (atrial fibrillation and atrial flutter). 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

What are the most common side effects?


Decreased white blood cells

Upper respiratory tract infection

Decreased platelet count

Bleeding

Rash

Muscle or joint pain



These are not all the possible side effects of BRUKINSA.
Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088.


How long will I be on treatment with BRUKINSA?

You will take BRUKINSA for as long as your doctor thinks it is helping you, or for as long as side effects are manageable.

About 25 months was the median duration of treatment for patients taking BRUKINSA in the clinical study. The median marks the midpoint where half of the patients were still taking BRUKINSA, while half were no longer on treatment.


Remember, everyone responds differently to treatment, so the length of time that you take BRUKINSA could be shorter or longer.


Treatment Response Category

Definition

Complete response (CR)

The disease has completely responded to treatment and there are no symptoms or signs of WM

Very good partial response (VGPR)

A small amount of disease can be detected, and there are no new symptoms or signs of WM

Partial response (PR)

The disease is still detectable, but there are no new symptoms or signs of WM

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