Learn more about LORBRENA (lorlatinib) and understand how it works

WHAT IS LORBRENA?

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LORBRENA is a prescription medicine that is used to treat adults with non-small cell lung cancer (NSCLC) that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene and that has spread to other parts of the body.

LORBRENA is available in a 100-mg strength tablet and a 25-mg strength tablet.

HOW LORBRENA WORKS

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LORBRENA was designed to inhibit the ALK protein, including ALK that has become resistant to other ALK inhibitors. Inhibiting the ALK protein can help LORBRENA slow the growth or spread of ALK+ tumors that have spread to other parts of the body.

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How LORBRENA Works in the Brain

The brain is a common site where ALK+ NSCLC spreads (metastasizes). One reason treating brain metastases can be challenging is that the medicine must cross the blood-brain barrier. The blood-brain barrier is a naturally occurring network of blood and tissue that helps prevent harmful substances, like bacteria, from entering the brain. LORBRENA was specifically designed to cross the blood-brain barrier and has been shown to help shrink ALK+ NSCLC tumors that have spread to the brain.

UNDERSTANDING LORBRENA
CLINICAL TRIAL RESULTS

LORBRENA Clinical Trial Results in Newly Diagnosed Patients

LORBRENA is being evaluated in a clinical trial. FDA approval for LORBRENA in newly diagnosed patients was based on an analysis of this trial at a median of 18 months of follow-up. These were the main results of the study. Patients in the trial were given one of two medicines, LORBRENA or crizotinib. Crizotinib is a different medicine for ALK+ NSCLC.

  • At enrollment, all patients were newly diagnosed with ALK+ NSCLC that had spread to other parts of their body
  • The study included patients with and without cancer that had spread to their brain
  • No patients had received any previous treatment for NSCLC that had spread to other parts of their body

The main result of the study was progression-free survival (PFS).

PFS results from the trial were analyzed at a median of 18 months. At that time, LORBRENA had reduced the chances of tumor growth by 72% compared to crizotinib.

More than half of the patients taking LORBRENA had not experienced tumor growth at the analysis with 18 months of follow-up. Therefore, the medianprogression-free survival for LORBRENA had not been reached yet. Patients taking crizotinib experienced cancer progression at a median of 9 months.

More time is needed to find out if patients taking LORBRENA live longer than patients taking crizotinib.


The analysis at a median of 18 months of follow-up also evaluated the overall response rate. This measures tumor response to treatment, including tumor shrinkage and disappearance, throughout the body including the brain. 76% of patients had their tumors shrink or disappear while taking LORBRENA.

In a clinical trial of newly diagnosed patients, 76% of patients had their tumors shrink or disappear with LORBRENA (lorlatinib) compared to 58% with crizotinib

    3% of patients taking LORBRENA had all signs of cancer disappear. This is known as a complete response. It does not mean the cancer is cured. 0% of patients taking crizotinib had all signs of cancer disappear.

    73% of patients taking LORBRENA had their tumors shrink. This is known as a partial response. 58% of patients taking crizotinib had their tumors shrink.

These responses lasted 12 months or longer in 70% of patients taking LORBRENA. They lasted 12 months or longer in 27% of patients taking crizotinib.


30 patients had measurable brain tumors when the clinical trial began. 17 of these patients were treated with LORBRENA and 13 were treated with crizotinib.

82% of newly diagnosed patients who had measurable brain tumors had their brain tumors shrink or disappear with LORBRENA (lorlatinib) compared to 23% with crizotinib

12 out of 17, or 71%, of patients taking LORBRENA had their brain tumors disappear. This is known as a complete response. It does not mean the cancer is cured. 2 out of 17, or 12%, of patients taking LORBRENA had their brain tumors shrink. This is known as a partial response.

82% of newly diagnosed patients who had measurable brain tumors had their brain tumors shrink or disappear with LORBRENA (lorlatinib) compared to 23% with crizotinib

1 out of 13, or 8%, of patients taking crizotinib had their brain tumors disappear. 2 out of 13, or 15%, of patients taking crizotinib had their brain tumors shrink.

These responses lasted 12 months or longer in 79% of patients treated with LORBRENA and 0% of patients treated with crizotinib.


The patients in the clinical trial are still being monitored and data are being collected and evaluated. A follow-up analysis was done at a median of 5 years, once more data were available.

This informal analysis was performed at a median of 5 years of follow-up. It was not designed to find specific differences between LORBRENA and crizotinib. Unlike the main analysis, the data did not undergo an additional independent review, and it was not used to support the FDA approval of LORBRENA. The scientists, medical professionals, and the investigators assessed the informal analysis at 5-years of follow-up data. The following were observed:

  • At 5 years, 60% of patients on LORBRENA had not experienced tumor growth. Therefore, the median (50%) progression-free survival still had not been reached
  • At 5 years, 8% of patients on crizotinib had not experienced tumor growth
  • At 5 years, LORBRENA had reduced the chances of tumor growth by 81% compared to crizotinib

No new safety concerns were detected in the follow-up analysis. The side effects experienced by patients in the main analysis were similar to those experienced in the follow-up analysis at a  median of 5 years.

LORBRENA Clinical Trial Results in Previously Treated Patients

LORBRENA was also evaluated in a clinical trial of 215 previously treated patients. The patients had ALK+ NSCLC that had spread to other parts of the body, including the brain. Their tumors were no longer responding to certain other medicines for ALK+ NSCLC.


This trial assessed the overall response rate in previously treated patients. In this trial, nearly half of patients had their tumors shrink or disappear with LORBRENA.

A study of previously treated patients achieved a 48% overall response rate with LORBRENA (lorlatinib)
  • 4% of patients treated with LORBRENA had all signs of cancer completely disappear. This is known as a complete response. It does not mean the cancer is cured
  • 44% of patients treated with LORBRENA had their tumors shrink. This is known as a partial response

These responses lasted for a median of 13 months.


A smaller group of 89 patients had measurable brain tumors* that were no longer responding to certain other medicines for ALK+ NSCLC. 60% of these patients had their brain tumors shrink or disappear with LORBRENA.

A group of patients who were no longer responding to certain other medicines for ALK positive NSCLC achieved a 60% overall response rate with LORBRENA
  • 19 out of 89, or 21%, of patients taking LORBRENA had their brain tumors completely disappear. This is known as a complete response. It does not mean the cancer is cured
  • 34 out of 89, or 38%, of patients taking LORBRENA had their brain tumors shrink. This is known as a partial response

These responses lasted for a median of 20 months.

*Of the 215 patients in the trial, 148 (69%) had brain tumors at the start of treatment. 89 of the 148 patients had brain tumors that could be measured.

A statistics term. The median is the middle value in a set of measurements.

A statistics term. The median is the middle value in a set of measurements.

A statistics term. The median is the middle value in a set of measurements.

A statistics term. The median is the middle value in a set of measurements.

Progression-free survival is the length of time patients are living without their tumors growing or spreading (“progressing”).

A statistics term. The median is the middle value in a set of measurements.

Progression-free survival is the length of time patients are living without their tumors growing or spreading (“progressing”).

A statistics term. The median is the middle value in a set of measurements.

A statistics term. The median is the middle value in a set of measurements.

The overall response rate measures tumor response to treatment, including tumor shrinkage and disappearance, throughout the body, including the brain.

In a complete response, all signs of cancer disappear. It does not mean the cancer is cured.

In a partial response, a tumor shrinks in response to treatment.

A measurable tumor is one that can be accurately measured in size. This information can be used to judge response to treatment.

In a complete response, all signs of cancer disappear. It does not mean the cancer is cured.

In a partial response, a tumor shrinks in response to treatment.

A statistics term. The median is the middle value in a set of measurements.

A statistics term. The median is the middle value in a set of measurements.

Progression-free survival is the length of time patients are living without their tumors growing or spreading (“progressing”).

A statistics term. The median is the middle value in a set of measurements.

A statistics term. The median is the middle value in a set of measurements.

Important Safety Information and Indication

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Important Safety Information
LORBRENA® (lorlatinib) may cause serious side effects, including:
  • Liver problems due to interactions with other medicines. It is important to know what medicines should not be taken with LORBRENA.
  • Central nervous system (CNS) effects. LORBRENA may cause CNS effects, including problems with thinking (such as forgetfulness or confusion), changes in mood (such as depression and thoughts about suicide or dying), psychotic effects such as seeing or hearing things that are not real (hallucinations), seizures, changes in speech and changes in sleep. Tell your healthcare provider if you experience new or worsening symptoms of CNS effects.
  • Increases in the cholesterol and triglycerides (lipid) levels in your blood. Most people will have an increase in the lipid levels in their blood during treatment with LORBRENA.
    • If you have increases in the lipid levels in your blood during treatment with LORBRENA, your healthcare provider may need to start you on a medicine to lower the levels. If you are already taking a medicine to lower the lipid levels in your blood, your healthcare provider may need to increase your dose of that medicine.
    • Your healthcare provider should do blood tests to check the lipid levels in your blood before starting treatment, 1 to 2 months after starting treatment, and during treatment with LORBRENA.
  • Heart problems. LORBRENA may cause very slow or abnormal heartbeats. Your healthcare provider should check your heart rhythm (electrocardiogram or EKG) before starting and during treatment with LORBRENA. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. In some people, these problems are severe, and your healthcare provider may need to have you stop taking LORBRENA or have a pacemaker placed.
  • Lung problems. LORBRENA may cause severe or life-threatening swelling (inflammation) of the lungs during treatment that can lead to death. Symptoms may be similar to those from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms of lung problems, including trouble breathing, shortness of breath, cough, or fever.
  • High blood pressure (hypertension). Your healthcare provider should check your blood pressure before starting treatment, 2 weeks after starting treatment, and then at least every month during treatment with LORBRENA. Your healthcare provider may need to start or change your blood pressure medicine if you have high blood pressure during treatment with LORBRENA. Tell your healthcare provider right away if you get signs or symptoms of high blood pressure, including headaches, dizziness, blurred vision, chest pain or shortness of breath.
  • High blood sugar (hyperglycemia). LORBRENA may increase your blood sugar levels. Your healthcare provider should do blood tests to check your blood sugar levels before starting and during treatment with LORBRENA. 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 high blood sugar, including feeling very thirsty, needing to urinate more than usual, or feeling very hungry, sick to your stomach, weak or tired, or confused.

If you have serious side effects during treatment with LORBRENA, your healthcare provider may change your dose, stop your treatment for a period of time, or completely stop treatment with LORBRENA.

Before taking LORBRENA, tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney problems
  • have had episodes of depression or seizures
  • have high levels of cholesterol or triglycerides in your blood
  • have problems with your heartbeat
  • have lung or breathing problems
  • have high blood pressure
  • have diabetes or high blood sugar
  • are pregnant or plan to become pregnant. LORBRENA can harm your unborn baby.
    • Your healthcare provider will do a pregnancy test before you start treatment with LORBRENA.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LORBRENA.
      • Females who are able to become pregnant should use effective non-hormonal birth control during treatment with LORBRENA and for at least 6 months after the final dose of LORBRENA. Birth control pills (oral contraceptives) and other hormonal forms of birth control may not be effective if used during treatment with LORBRENA. Talk to your healthcare provider about birth control choices that are right for you during this time.
      • Males who have female partners who are able to become pregnant should use effective birth control during treatment with LORBRENA and for at least 3 months after the final dose of LORBRENA.
  • are breastfeeding or plan to breastfeed. It is not known if LORBRENA passes into your breast milk. Do not breastfeed during treatment with LORBRENA and for 7 days after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. LORBRENA may affect the way other medicines work and other medicines may affect the way LORBRENA works, causing side effects.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

Do not take LORBRENA if you take certain other medicines called strong CYP3A inducers. Ask your healthcare provider for a list of these medicines if you are not sure.

The most common side effects of LORBRENA include:

  • swelling in your arms, legs, hands, and feet (edema)
  • numbness and tingling feeling in your joints or arms and legs (peripheral neuropathy)
  • weight gain
  • problems with thinking, such as forgetfulness or confusion
  • tiredness (fatigue)
  • difficulty breathing
  • pain in your joints
  • diarrhea
  • changes in mood, such as depression and irritability
  • high cholesterol and triglyceride levels in the blood
  • cough

LORBRENA may cause decreased fertility in males. In males, this could affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of LORBRENA. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Indication

LORBRENA is a prescription medicine that is used to treat adults with non-small cell lung cancer (NSCLC) that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene and that has spread to other parts of your body.

Your healthcare provider will perform a test to make sure that LORBRENA is right for you.

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

Please see Full Prescribing Information and Patient Information.

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(US only). If you prefer, you may contact the US Food and Drug Administration (FDA) directly.

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The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.

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Last Updated: July 2024 PP-LOR-USA-0655

LORBRENA® is a registered trademark of Pfizer Inc.