BRUKINSA is a BTK inhibitor that was designed to block BTK
- BRUKINSA has been shown to block 100% of BTK in blood cells and 94% to 100% of BTK in lymph nodes when taken at the recommended total daily dose of 320 mg. The significance of blocking up to 100% of BTK on treatment responses has not been established
Why is a BTK inhibitor important for CLL/SLL treatment?
- Bruton’s tyrosine kinase (BTK) is a protein that signals to cancerous B cells (like those that cause CLL or SLL), helping them to grow and spread
- Blocking BTK can help stop this signaling
In 2 trials directly comparing BRUKINSA to other approved CLL/SLL treatment options, significantly more patients taking BRUKINSA achieved better results
A diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) can be difficult and overwhelming. That’s why it is important to discuss the benefits and risks of treatment options and
responses with your doctor.
In the BRUKINSA trials, 2 types of responses were studied. Progression-free survival (PFS), or the rate at which patients live without their disease worsening, was 1 response and the main purpose of this study. The other response, and a secondary purpose of this study, was overall response rate (ORR), or the percentage of patients in which treatment is working.
Talking to your doctor about these responses can help you find the treatment option
that may be right for you.
In a trial comparing BRUKINSA to a combination therapy known as BR, more patients taking BRUKINSA continued responding to treatment with no sign of CLL/SLL worsening
The trial included 589 patients who had never received treatment for their CLL/SLL. 479 patients in the trial who did not have a genetic mutation known as del(17p) received either BRUKINSA or BR, which is a combination of bendamustine (a type of chemotherapy) and rituximab (a targeted therapy). There were also 110 patients with the del(17p) mutation who received BRUKINSA in a separate treatment arm.
At 2 years, more patients taking BRUKINSA continued responding to treatment with no sign of CLL/SLL worsening
- 58% relative reduction in the risk of CLL/SLL worsening for patients taking BRUKINSA compared to those taking BR
At 2 years, more patients taking BRUKINSA saw an improvement* in their CLL/SLL, compared to those taking BR
*When patients improved, tests showed that their cancer got smaller in size and did not spread.
Patients with the del(17p) mutation responded to treatment with BRUKINSA
Certain people with CLL/SLL have a genetic mutation called del(17p). Because these patients don’t usually respond well to chemoimmunotherapy, they were studied separately to see how they'd respond to just BRUKINSA.
2-Year Progression-Free Survival:
with del(17p)
(110 BRUKINSA patients)
Individual results may vary.
Fewer patients stopped treatment with BRUKINSA because of side effects than those taking BR
Patients who took BRUKINSA reported low rates of atrial fibrillation or flutter (an irregular or rapid heart rate rhythm)
More patients taking BRUKINSA continued to live without their CLL/SLL worsening than those taking BR
Living with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) is a long road with unique challenges at each turn, and every person has different treatment goals. That’s why it is important to discuss the benefits and risks of treatment options and responses with your doctor.
In the BRUKINSA trials, 2 types of responses were studied. Overall response rate (ORR), or the percentage of patients in which treatment is working, was the main purpose of this study. The other response and a secondary purpose of this study was progression-free survival (PFS), or the rate at which patients live without their disease worsening.
Talking to your doctor about these responses can help you find the next treatment option
that may be right for you.
In a trial comparing BRUKINSA to ibrutinib, significantly more patients responded to BRUKINSA
The trial included 652 patients who had received at least 1 prior treatment for their CLL/SLL. Patients in the trial received either BRUKINSA or ibrutinib, another BTK-targeted treatment.
At 2 years, more patients taking BRUKINSA saw an improvement* in their CLL/SLL, compared to those
taking ibrutinib
*When patients improved, tests showed that their cancer got smaller in size and did not spread.
At 2 years, more patients taking BRUKINSA continued responding to treatment with no sign of CLL/SLL worsening, compared to those taking ibrutinib
- 35% relative reduction in the risk of CLL/SLL worsening for patients taking BRUKINSA compared to those taking ibrutinib
These results presented are consistent with, but not included in,
the FDA-approved prescribing information.
Patients with the del(17p) mutation responded to treatment with BRUKINSA
2-Year Progression-Free Survival:
with del(17p)
These results presented are consistent with, but not included in, the
FDA-approved prescribing information.
Individual results may vary.
Fewer patients stopped treatment with BRUKINSA because of side effects than those taking ibrutinib
Fewer patients reported atrial fibrillation or flutter (an irregular and rapid heart rhythm) with BRUKINSA than those
taking ibrutinib
More patients taking BRUKINSA saw an improvement in their CLL/SLL than those taking ibrutinib
An additional long-term, supportive study of BRUKINSA showed that patients taking BRUKINSA continued to respond to treatment for nearly 4 years
This BRUKINSA-only study included CLL/SLL patients, some of whom received BRUKINSA as their first treatment and some of whom received BRUKINSA after receiving a prior treatment.
These results presented are consistent with, but not included in,
the FDA-approved prescribing information.
Individual results may vary.
Side effects with BRUKINSA
People taking BRUKINSA may experience side effects. In CLL/SLL clinical trials, 8% of previously untreated and 15% of previously treated patients discontinued treatment due to side effects. It’s important to remember that everyone responds to medication differently.
Speak to your doctor about side effects of concern. Most side effects can be managed by your doctor to help you feel better and stay on treatment. Be sure to tell your doctor right away about any new or worsening side effects.
The most common side effects of BRUKINSA include:
- Decreased white blood cell count
- Upper respiratory tract infection
- Decreased platelet count
- Bleeding
- Muscle, bone, or joint pain
BRUKINSA may cause serious side effects, including:
- Bleeding problems (hemorrhage). Bleeding problems are common with BRUKINSA, and 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 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 (white blood cells, platelets, and red blood cells). 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. Use sun protection when you are outside in sunlight
- Heart rhythm problems (atrial fibrillation, atrial flutter, and ventricular arrhythmias) that can be serious and may lead to death. 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
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 FDA at 1-800-FDA-1088.
If side effects occur, partnering with your doctor can help you manage any symptoms you may experience and may help ensure you can continue treatment with BRUKINSA.
You will continue to take BRUKINSA for as long as your doctor thinks it is helping you, or for as long as side effects are manageable.