How ALUNBRIG® (brigatinib) May Help As Your First Targeted Treatment for ALK+ Metastatic Non-Small Cell Lung Cancer

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ALUNBRIG was evaluated in a broad range of patients, including those with ALK+ NSCLC that had spread to other parts of their body

The ALUNBRIG study included 275 patients with ALK+ NSCLC whose lung cancer had spread to other parts of their body.

137 patients received the recommended dosing regimen of 90 mg of ALUNBRIG orally once daily for 7 days, followed by an increase to 180 mg orally once daily. The other 138 patients received a different medicine called crizotinib.

  • Patient ages ranged from 27 years to 89 years (median age was 59 years) and about half (55%) were female
  • 58% of patients in the study had never smoked

Patients taking ALUNBRIG went twice as long without their disease getting worse or spreading versus those taking crizotinib

BLINDED INDEPENDENT REVIEW COMMITTEE RESULTS

MEDIANa TIME TO PROGRESSION    

Bar chart showing that the median time to progression for patients taking ALUNBRIG® was 24 months versus 11 months for patients taking crizotinib.

aMedian is not the same as average. Please see glossary for definition

BLINDED INDEPENDENT REVIEW COMMITTEE
This was a group of independent researchers who objectively reviewed and evaluated the results from the trial.

OVERALL

3 out of 4.

Overall, 3 out of 4 patients (74%) taking ALUNBRIG had their tumors shrink, vs 62% of patients taking crizotinib.

101 of 137 patients (74%) taking ALUNBRIG had their tumors shrink vs 85 of 138 patients (62%) taking crizotinib.

ALUNBRIG Helped Shrink Tumors in the Brain

Additional Study Results

The Blinded Independent Review Committee also evaluated a smaller group of 41 patients with brain metastases.

Overall, 14 of 18 patients (78%) achieved a response while taking ALUNBRIG vs 6 of 23 patients (26%) taking crizotinib

  • 3 out of every 4 patients with cancer that spread to their brain saw their tumors shrink when they were treated with ALUNBRIG

More than half of all patients (9 out of 14) who responded to ALUNBRIG maintained that response for 2 years or longer

  • Researchers could not estimate the results for the 6 patients who responded to treatment with crizotinib

People Reported a Better Quality of Life with ALUNBRIG

During the study, 131 people taking ALUNBRIG completed a quality of life questionnaire.

Results from the questionnaire showed that people receiving ALUNBRIG went THREE TIMES LONGER without the symptoms of their cancer getting worse compared to patients treated with crizotinib.

  • This means that the average time to symptoms getting worse was 26.7 months for patients taking ALUNBRIG compared with 8.3 months for patients taking crizotinib
  • The study measurement included how people functioned with the disease (physical, emotional and social functioning) and the severity of the symptoms they experienced

The results of this survey weren't originally a part of the study. Patients also knew which medicine they were taking during the study. This means that patients may have marked their quality-of-life improvements higher than they actually were.

Every patient is different. Always talk to your doctor if you have any questions about ALUNBRIG.

It's normal to have questions as you begin your treatment on ALUNBRIG

We have additional resources for you to discuss with your healthcare provider as you get started.

See Additional Resources

Glossary

  • Median – The middle number in a set of measurements arranged from lowest to highest.

IMPORTANT SAFETY INFORMATION, INDICATION, AND USAGE

Expand+

ALUNBRIG can cause serious side effects, including:

  • Lung problems. ALUNBRIG may cause severe or life-threatening swelling (inflammation) of the lungs any time during treatment and can lead to death. These lung problems happen especially within the first week of treatment with ALUNBRIG. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms. including: 
    • trouble breathing or shortness of breath
    • chest pain
    • cough with or without mucus
    • fever
       
  • High blood pressure (hypertension). ALUNBRIG may cause high blood pressure. Your healthcare provider will check your blood pressure before starting and during treatment with ALUNBRIG. Tell your healthcare provider right away if you get headaches, dizziness, blurred vision, chest pain or shortness of breath.
     
  • Slow heart rate (bradycardia). ALUNBRIG may cause very slow heartbeats that can be severe. Your healthcare provider will check your heart rate during treatment with ALUNBRIG. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint during treatment with ALUNBRIG. Tell your healthcare provider if you take any heart or blood pressure medicines.
     
  • Vision problems. ALUNBRIG may cause vision problems. Your healthcare provider may stop ALUNBRIG and refer you to an eye specialist if you develop severe vision problems during treatment with ALUNBRIG. Tell your healthcare provider right away if you have any loss of vision or any change in vision, including:
    • double vision
    • seeing flashes of light
    • blurry vision
    • light hurting your eyes
    • new or increased floaters
       
  • Muscle pain, tenderness, and weakness (myalgia). ALUNBRIG may increase the level of an enzyme in your blood called creatine phosphokinase (CPK), which may be a sign of muscle damage. Your healthcare provider will do blood tests to check your blood levels of CPK during treatment with ALUNBRIG. Tell your healthcare provider right away if you get new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.
     
  • Inflammation of the pancreas (pancreatitis). ALUNBRIG may increase enzymes in your blood called amylase and lipase, which may be a sign of pancreatitis. Your healthcare provider will do blood tests to check your pancreatic enzyme blood levels during treatment with ALUNBRIG. Tell your healthcare provider right away if you get new or worsening signs and symptoms of pancreatitis, including upper abdominal pain that may spread to the back and get worse with eating, weight loss, or nausea.
     
  • Liver problems (hepatotoxicity). ALUNBRIG may increase the levels of bilirubin in your blood and enzymes called aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in your blood, which may be a sign of liver problems. Your healthcare provider will do blood tests to check your liver during treatment with ALUNBRIG. Tell your healthcare provider right away if you get new or worsening signs or symptoms, including:
    • yellowing of your skin or the white part of your eyes
    • dark or brown (tea color) urine
    • nausea or vomiting
    • pain on the right side of your stomach area
    • bleed or bruise more easily than normal
    • itchy skin
    • decreased appetite
    • feeling tired
       
  • High blood sugar (hyperglycemia). ALUNBRIG may increase your blood sugar levels. Your healthcare provider will do blood tests to check your blood sugar levels before starting and during treatment with ALUNBRIG. Your healthcare provider may need to start or change your blood sugar medicine to control your blood sugar levels. Tell your healthcare provider right away if you get new or worsening signs and symptoms of hyperglycemia, including:
    • feeling very thirsty
    • needing to urinate more than usual
    • feeling very hungry
    • feeling sick to your stomach
    • feeling weak or tired
    • feeling confused

The most common side effects of ALUNBRIG include diarrhea, fatigue, nausea, rash, cough, muscle pain, headache, high blood pressure, vomiting and difficulty breathing.

ALUNBRIG may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

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

What should I avoid while taking ALUNBRIG?

  • Limit your time in the sun during treatment with ALUNBRIG and for at least 5 days after your final dose. ALUNBRIG may make your skin sensitive to sunlight. You may burn more easily and get severe sunburns. When you are in the sun, wear a hat and protective clothing, and use a broad-spectrum sunscreen and lip balm with a Sun Protection Factor (SPF) of 30 or greater to protect against sunburn.
  • Avoid eating grapefruit or drinking grapefruit juice during treatment with ALUNBRIG. Grapefruit may increase the amount of ALUNBRIG in your blood.

Before you take ALUNBRIG, tell your healthcare provider about all of your medical conditions, including if you have lung or breathing problems, high blood pressure, a slow heartbeat, or any vision problems, have or have had pancreatitis, have liver problems, have diabetes mellitus or glucose intolerance, have kidney problems or are on dialysis, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

  • ALUNBRIG can harm your unborn baby. Your healthcare provider will determine whether or not you are pregnant before you start treatment with ALUNBRIG. Tell your healthcare provider right away if you become pregnant during treatment with ALUNBRIG or think you may be pregnant.
    • Females who are able to become pregnant should use effective birth control during treatment with ALUNBRIG and for at least 4 months after the final dose of ALUNBRIG. Talk to your healthcare provider about birth control choices that are right for you during treatment with ALUNBRIG.
    • Males who have female partners who are able to become pregnant should use effective birth control during treatment with ALUNBRIG and for at least 3 months after the final dose of ALUNBRIG.
  • It is not known if ALUNBRIG passes into your breast milk. Do not breastfeed during treatment with ALUNBRIG and for 1 week after the final dose of ALUNBRIG.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements.

Please read the Patient Information in the full Prescribing Information and discuss with your healthcare provider.

What is ALUNBRIG?

ALUNBRIG is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC):

  • that has a certain type of abnormal anaplastic lymphoma kinase (ALK) gene, and
  • that has spread to other parts of your body

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

IMPORTANT SAFETY INFORMATION

ALUNBRIG can cause serious side effects, including:

  • Lung problems. ALUNBRIG may cause severe or life-threatening swelling (inflammation) of the lungs any time during treatment and can lead to death. These lung problems happen especially within the first week of treatment with ALUNBRIG. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms. including: 
    • trouble breathing or shortness of breath
    • chest pain
    • cough with or without mucus
    • fever
       
  • High blood pressure (hypertension). ALUNBRIG may cause high blood pressure. Your healthcare provider will check your blood pressure before starting and during treatment with ALUNBRIG. Tell your healthcare provider right away if you get headaches, dizziness, blurred vision, chest pain or shortness of breath.
     
  • Slow heart rate (bradycardia). ALUNBRIG may cause very slow heartbeats that can be severe. Your healthcare provider will check your heart rate during treatment with ALUNBRIG. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint during treatment with ALUNBRIG. Tell your healthcare provider if you take any heart or blood pressure medicines.
     
  • Vision problems. ALUNBRIG may cause vision problems. Your healthcare provider may stop ALUNBRIG and refer you to an eye specialist if you develop severe vision problems during treatment with ALUNBRIG. Tell your healthcare provider right away if you have any loss of vision or any change in vision, including:
    • double vision
    • seeing flashes of light
    • blurry vision
    • light hurting your eyes
    • new or increased floaters
       
  • Muscle pain, tenderness, and weakness (myalgia). ALUNBRIG may increase the level of an enzyme in your blood called creatine phosphokinase (CPK), which may be a sign of muscle damage. Your healthcare provider will do blood tests to check your blood levels of CPK during treatment with ALUNBRIG. Tell your healthcare provider right away if you get new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.
     
  • Inflammation of the pancreas (pancreatitis). ALUNBRIG may increase enzymes in your blood called amylase and lipase, which may be a sign of pancreatitis. Your healthcare provider will do blood tests to check your pancreatic enzyme blood levels during treatment with ALUNBRIG. Tell your healthcare provider right away if you get new or worsening signs and symptoms of pancreatitis, including upper abdominal pain that may spread to the back and get worse with eating, weight loss, or nausea.
     
  • Liver problems (hepatotoxicity). ALUNBRIG may increase the levels of bilirubin in your blood and enzymes called aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in your blood, which may be a sign of liver problems. Your healthcare provider will do blood tests to check your liver during treatment with ALUNBRIG. Tell your healthcare provider right away if you get new or worsening signs or symptoms, including:
    • yellowing of your skin or the white part of your eyes
    • dark or brown (tea color) urine
    • nausea or vomiting
    • pain on the right side of your stomach area
    • bleed or bruise more easily than normal
    • itchy skin
    • decreased appetite
    • feeling tired
       
  • High blood sugar (hyperglycemia). ALUNBRIG may increase your blood sugar levels. Your healthcare provider will do blood tests to check your blood sugar levels before starting and during treatment with ALUNBRIG. Your healthcare provider may need to start or change your blood sugar medicine to control your blood sugar levels. Tell your healthcare provider right away if you get new or worsening signs and symptoms of hyperglycemia, including:
    • feeling very thirsty
    • needing to urinate more than usual
    • feeling very hungry
    • feeling sick to your stomach
    • feeling weak or tired
    • feeling confused

The most common side effects of ALUNBRIG include diarrhea, fatigue, nausea, rash, cough, muscle pain, headache, high blood pressure, vomiting and difficulty breathing.

ALUNBRIG may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

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

What should I avoid while taking ALUNBRIG?

  • Limit your time in the sun during treatment with ALUNBRIG and for at least 5 days after your final dose. ALUNBRIG may make your skin sensitive to sunlight. You may burn more easily and get severe sunburns. When you are in the sun, wear a hat and protective clothing, and use a broad-spectrum sunscreen and lip balm with a Sun Protection Factor (SPF) of 30 or greater to protect against sunburn.
  • Avoid eating grapefruit or drinking grapefruit juice during treatment with ALUNBRIG. Grapefruit may increase the amount of ALUNBRIG in your blood.

Before you take ALUNBRIG, tell your healthcare provider about all of your medical conditions, including if you have lung or breathing problems, high blood pressure, a slow heartbeat, or any vision problems, have or have had pancreatitis, have liver problems, have diabetes mellitus or glucose intolerance, have kidney problems or are on dialysis, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

  • ALUNBRIG can harm your unborn baby. Your healthcare provider will determine whether or not you are pregnant before you start treatment with ALUNBRIG. Tell your healthcare provider right away if you become pregnant during treatment with ALUNBRIG or think you may be pregnant.
    • Females who are able to become pregnant should use effective birth control during treatment with ALUNBRIG and for at least 4 months after the final dose of ALUNBRIG. Talk to your healthcare provider about birth control choices that are right for you during treatment with ALUNBRIG.
    • Males who have female partners who are able to become pregnant should use effective birth control during treatment with ALUNBRIG and for at least 3 months after the final dose of ALUNBRIG.
  • It is not known if ALUNBRIG passes into your breast milk. Do not breastfeed during treatment with ALUNBRIG and for 1 week after the final dose of ALUNBRIG.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements.

Please read the Patient Information in the full Prescribing Information and discuss with your healthcare provider.

What is ALUNBRIG?

ALUNBRIG is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC):

  • that has a certain type of abnormal anaplastic lymphoma kinase (ALK) gene, and
  • that has spread to other parts of your body

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